Pipeline 2007

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Details of more than 250 therapeutics and vaccines in development, including analyst comments on key products.

Cardiovascular
Generating Buzz:

Torcetrapib Pfizer
Expectations are high for torcetrapib. Pfizer is hoping this compound will come to the rescue of its $12 billion-seller Lipitor, when its patent expires in 2010. “There's a huge market 25-27 billion worldwide dollars in terms of sales across the dyslipidemia marketplace and this marketplace is evolving,” says Rob Delghiaccio, GfK Market Measures category business leader, cardiovascular.  “Our data indicate that for physicians, it's not just a matter of getting patients' LDL lowered. It's a matter of lowering total cholesterol and raising the good cholesterol. Torcetrapib is focused on the mechanism of action to raise good cholesterol or HDL.” Deutsche Bank pharmaceuticals analyst Barbara Ryan says, “There's no question that HDL as a separate risk factor is going to get increased attention and this may be the first major therapy.”

Exforge (valsartan/amlodipine) Novartis
Novartis' Exforge aims to lower blood pressure through two different mechanisms of action—calcium channel blocker Norvasc (amlodipine) and angiotensin receptor blocker Diovan (valsartan)—both the number one prescribed medications in their respective classes.

Diovan is predicted to be a $4 billion drug for 2006 while Norvasc sales are projected at $5 billion. Norvasc goes off patent in 2007.

“From that perspective, Exforge seems to be a drug that is particularly a great opportunity out there considering the two components that make it up are received so well in the marketplace,” says GfK's Delghiaccio. “We are talking about a hypertension marketplace affecting upwards of 65 million Americans that's 20-25% of the adult population. So, when you combine the two products, Diovan and Norvasc to form Exforge, the opportunities are tremendous. Our data has shown us that physicians want to treat hypertension earlier in the process”

Tekturna (aliskiren) Novartis
Previously know as Rasilez, Tekturna blocks the activity of the rennin enzyme, one of the mechanisms by which hypertension occurs. Typically patients with hypertension have the propensity to wake up with a blood pressure surge; Tekturna is designed to maintain blood pressure levels over a 24-hour dosing period. Novartis could have a blockbuster on their hands as analysts predict sales of between $1 billion to $2 billion for this first-in-class drug. Merck is reportedly working on drugs similar to Tekturna. Tekturna has been submitted for FDA approval with a decision anticipated for sometime in early 2007.

Prasugrel Eli Lilly/Daiichi Sankyo
Early indications are that the drug is expected to file in 2007.

This platelet inhibitor is in a head-to-head studies against Bristol-Myers Squibb/Sanofi-Aventis' Plavix. Acute coronary syndrome would compete with Plavix, a $4 billion a year drug. “This is clearly is a huge opportunity for Lilly, the most important in their pipeline,” says Deutsche Bank's Ryan. Prasugrel could tap a massive market if it proves to reduce cardiovascular events better than Plavix.



Diabetes
Generating Buzz

Acomplia Sanofi-Aventis
Acomplia's mechanism of action helps to inhibit the endocannabinoid system, which creates hunger cravings in the brain.

Acomplia is currently available in Europe and Mexico as a combination treatment for patients with Type 2 diabetes and as a diet and exercise alternative for overweight patients not afflicted by diabetes.

 “Diabetics are more likely than the general population to be obese,” explains Dave Jacobsen, SVP of the Roper Global Diabetes Management Program, GfK. “So, the promise of helping patients control their appetite, reduce food intake and slow its absorption into the system could have a significant impact on people's ability to control blood sugar levels. (Acomplia) will have to be looked at as a combination treatment to be taken along with diabetes medications.”

In February, Sanofi-Aventis received an approvable letter for use of Acomplia as an obesity treatment, but the FDA deemed the drug “non-approvable” as a smoking cessation treatment. Outright US approval is expected in early 2007. Analysts predict a blockbuster three times over, but, with an estimated price tag of $100 for a month's supply, the drug may need a major marketing push to help it achieve its sales potential.

Galvus Novartis
Galvus, if approved, will face fierce competition in the growing diabetes treatment market, most likely from relative newcomers— Lilly's Byetta (approved in April), Pfizer's Exubera (approved in January) and the in-class rival Merck's Januvia (approved in October). Both Galvus and Januvia are DPP-4 (dipeptidyl-peptidase 4) inhibitors, which enhance the body's ability to lower elevated blood sugar. Januvia was approved by the FDA in October. Meanwhile Galvus is still awaiting an FDA nod. In November, Novartis asked the FDA to extend the review period for Galvus by three months to allow the agency to examine new clinical trials data. In other words, it's still too early to tell how this new market will shape up.

One thing is certain, according to Lehman Brothers large caps pharmaceutical analyst Tony Butler. “The DPP-4 inhibitors offer enhanced utitilty to Type 2 diabetics over some of the existing therapies,” he says. “There may be some similar agents beyond these but they may be too early in development to make judgments right now.”

Dave Jacobsen, SVP of the Roper Global Diabetes Management Program, GfK, says, “This could become a very crowded marketplace. We see no abatement in the growth of Type 2 diabetes. That's the simplest answer. It's still an epidemic in this country. That said, there will be considerable potential for these products.”

Technosphere MannKind  
The approval in January of Pfizer's Exubera inhaled insulin was followed by reports that rival formulations are also seeing promising trials results. The Technosphere delivery system is rumored to work faster than Exubera and other inhaled insulins in development. With this in mind some analysts are predicting sales of $500 million by 2015. To ring in these kinds of sales, MannKind must first find a suitable marketing partner, analysts say. Technosphere is currently in Phase III clinical and is expected to file for approval in 2008.

Meanwhile, Pfizer's first-to-market Exubera has had its share of delays and is not due to hit the market with force until January or February 2007. “When you look at the scripts for Exubera now, it's kind of pathetic,” says Deutsche Bank's Ryan.

“Once we get into the first quarter of 2007 we will have something more representative (of what the market could look like),” she says.



Central Nervous System
Generating Buzz

Alzhemed (tramiprosate) Neurochem
Flurizan MPC-7869 Myriad Genetics
A new cadre of compounds seeks to modify the brain processes that cause Alzheimer's disease. Alzhemed and Flurizan reduce amyloid deposits in the brain. Both compounds are in Phase III trials in the US. These so-called modifying drugs would offer an advantage over Aricept, Exelon, Razadyne and Namenda which relieve some symptoms  and slow progression, but do not stop it. “So far this is an extremely unfulfilled marketplace,” says Kim Lazarus, GfK Market Measures.

Frisium Ovation
About a quarter of neurologists report hearing about receptor antagonist Frisium, which, already approved in Canada, is in Phase II trials in the US. Cometition will come from Eisai/Novartis rufinamide, which received an FDA approvable letter in September, and lacosamide from Schwarz, in Phase III trials.

Bifeprunox Solvay with Wyeth
Asenapine Akzo Nobel with Pfizer
Partial agonists can increase dopamine activity in one part of the brain while diminishing it in others, correcting chemical imbalances in patients suffering from schizophrenia and bipolar disorder. Bifeprunox and Asenapine are in Phase III trials. Products with new mechanisms of action can differentiate themselves in this market, says Geoff Penney, category business leader, psychiatry, GfK. Yet data indicate challenges. Akzo announced mixed results for schizophrenia patients taking Asenapine. Such issues could exacerbate problems with compliance and persistency.

Gaboxodol Lundbeck with Merck
Sleep aid gaboxodol touts a different mechanism of action from non-benzodiazepines like Ambien and Lunesta. That may give it less potential for addiction. But, warns Penney, it may not achieve the same efficacy, something that may hinder its success. “Less potential for addiction is important for this market but must be accompanied by equal efficiency to those non-benzodiazepines,” he says.



Oncology
Generating Buzz

Provenge (sipuleucel-T) Dendreon
Targeted therapies are among the most promising in cancer. Provenge is actually a vaccine designed to stimulate the patient's own immune system to target a tumor antigen called PAP found in 95% of prostate cancers. “[Provenge] has the cachet of being a very scientific approach rather than your typical chemotherapy shotgun,” says Michael Galvin, Ph.D., vice president, GfK V2. Submitted in August, the product is under fast-track review. Phase III trials showed a significant number of men with early and advanced stages of prostate cancer benefited. While not inexpensive, the infusion therapy has shown reasonable safety and efficacy in a disease with few options. The only approved therapy is Taxotere (docetaxel), which can keep people alive for months.

Tykerb (lapatinib) GlaxoSmithKline
Tyrosine kinase inhibitors are another targeted therapy. Lapatinib may block two different receptors, HER1 and HER2, which has a role in a subset of breast cancer. The promise of lapatinib is first, it's given orally once a day (Genentech's approved antibody Herceptin is given intravenously every month). Second, it can help reduce the development of brain metastases, a problem with breast cancer. An international trial with oral chemo agent Xeloda worked so well that it was stopped early. Analysts say Tykerb, which is awaiting US and European approval, could bring in more than $1 billion yearly.

CP-675,206 Pfizer
Ipilimumab/MDX-010 Medarex with Bristol-Myers Squibb
Nothing has been shown to adequately improve outcomes in melanoma in 30 years, so there's a great deal of excitement among doctors about these two monoclonal antibodies. They work by binding to CTLA-4, a molecule on T cells that is believed responsible for suppressing immune response. Both are in phase III, and responses have been encouraging: “People can live years, decades out, who normally have a life expectancy of about six months,” says Galvin.



Respiratory
Generating Buzz

Combo spray: Allermist (fluticasone) GlaxoSmithKline
“Allergic rhinitis is not a category that's dramatically underserved,” explains Lazarus, category business leader, respiratory & neurology, GfK Market Measures. “Doctors are fairly comfortable with what's out there.” Nevertheless, the rate of physician awareness for investigational combination products runs high, because of the need for better compliance. Among the most anticipated respiratory compounds is Allermist. It addresses nasal and ocular (itchy eye) symptoms of the condition, a combination which is not a focal point of any approved drug. The product is in Phase III clinical trials and was slated for submission in 2006. Others firms are putting allergy combo products together. Alcon plans to file a US marketing application for a nasal spray formulation of its Patanol (olopatadin) ocular allergy drug in 2007. Physicians rate the Alcon and GSK combo drugs relatively high in terms of expected usefulness, Lazarus says.

Xyzal (levocetirizine) UCB Pharma with Sanofi-Aventis
This once-daily antihistamine for seasonal and perennial allergic rhinitis was first launched in Europe in 2001 and is marketed in 49 countries. Still, it's not on US physicians' radar screens yet, says Lazarus. That may change. UCB Pharma, which licensed the European patents to levocetirizine back in 1999, earlier this year optioned the US patents, as well, from Sepracor. It then turned around and inked a US co-promotion agreement with marketing giant Sanofi-Aventis, under which the two would share profits from Xyzal. UCB submitted Xyzal to the FDA in July and is awaiting approval.

Flutiform (formoterol + fluticasone) SkyePharma with Abbott
Asthma is another category seeing new combinations, in this case joining long-acting bronchodilators to open airways and prevent asthma attacks with corticosteroids to reduce irritation and swelling in air passages. Flutiform follows the pattern, uniting formoterol with fluticasone in an inhaler. Unable to find a late-stage development partner for Flutiform, SkyePharma decided to take the drug through trials itself. It's in Phase III for asthma in adults and adolescents, and SkyePharma expects US filing in 2007. “Physicians are seeing it as a positive for the category,” Lazarus says, although their clinical experience with Flutiform is low. US marketing rights to Flutiform belong to Kos, the specialty firm being purchased by drug giant Abbott. The market is dominated by GSK's Advair Diskus (salmeterol + fluticasone). SkyePharma claims formoterol takes effect more rapidly than salmeterol and that US physicians prefer the safety and efficacy profile of fluticasone over budesonide, the steroid in AstraZeneca's forthcoming Symbicort (formoterol + budesonide), due to launch mid-2007. Physician ratings of Flutiform for use in this disease state are relatively high, Lazarus notes.



Others
Generating Buzz

Cervarix GlaxoSmithKline
Cervarix is GlaxoSmithKline's answer to Merck's much heralded Gardasil, which was approved by the FDA in June 2006. The vaccine is for the prevention of cervical cancer caused by the human papilloma virus. GSK is targeting submission by the end of 2006.

The market for Cervarix is still immature with plenty of potential for growth, says Sue Ramspacher, category business leader, female health, GfK Market Measures. “With Gardasil bringing in $70 million in its first quarter, the perception is that it is certainly being well received,” she says. “It's also being well received by managed care organizations.”

Wall Street analysts project Gardasil sales to reach over $1 billion by 2010. GSK hopes the scenario for Cervarix is similar, assuming US regulators give grant the vaccine market approval.

Telaprevir Vertex Pharmaceuticals
One of the most anticipated developments on the way for Hepatitis C (HCV) is Vertex Pharmaceuticals' STAT-C (Specifically Targeted Anti-viral Therapy-HCV), Telaprevir (VX-950), presently in Phase IIb clinical development. “There is an immense unmet need in the treatment of HCV because many of the current therapies available are not necessarily highly effective,” says Noah Pines, EVP, GfK V2.

Telaprevir is being studied for use in combination with pegylated interferon and ribavirin and presented encouraging data at the October American Association for the Study of Liver Diseases meeting in Boston. Results showed that 24 of 26 patients who received Telaprevir, followed by six months of standard therapy, had undetectable levels of the virus, and many had a sustained response after three months without additional treatment. If approved, Telaprivir would be the first-in-class HCV protease inhibitor creating a new market. Schering-Plough is also working on a similar compound that has yet to be named.

Cimzia (certolizumab pegol) UCB Pharma/Nektar
This pegalated anti-TNF agent from UCB Pharma is on track to get a possible initial indication for Crohn's disease next year. But, like other drugs in its class, Cimzia may be effective against a range of autoimmune inflammatory diseases, including rheumatoid arthritis in 2008 and psoriasis 2010-2012. If it achieves a label for Crohn's by early 2007—for which it has been filed in the US and EU—Cimzia could beat Abbott's RA drug Humira to the punch. Humira is being studied in Crohn's, among other indications. One potential advantage of Cimzia: once-a-month administration, thanks to Nektar's Advanced PEGylation delivery technology. Patients with RA and severe Crohn's would need weekly Humira injections. In addition, notes GfK V2 executive vice president John Taenzler, Ph.D., Cimzia comes from a viral source, so manufacturing is less expensive. “Considering these drugs cost $10,000-$15,000 a year, any sort of cost benefit could give [Cimzia] a huge advantage,” he says.

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