Savient Pharma Receives Bad News Concerning KRYSTEXXA

This was on PR Newswire for Savient Pharma. Tough news for their Gout Treatment. Expect a huge downfall in stock price this week. In addition to Savient, there are other competitors out there with approvals so this is really bad news for Savient. However, I say wait for it to drop and buy it up on its low point. This lowpoint will probably will be reached sometime this week.

Uloric, from Takeda Pharmaceutical, was approved in February. Expect a huge swing in Takeda Pharma this week with this unexpected news. Previously, an advisory committee approved the drug, Krystexxa, so this is a shock for Savient as it was advised on a 14-1 vote. This just goes to show how volatile and risky Biotech stocks can be. Now this can be turned around, but it will take some tweaking in the lab and further involvement with Contract Manufacturing of the medication. Again tough news for Savient Pharma.

Also, another treatment for Gout was approved just last week. The company is Mutual Pharmaceutical out of Philadelphia, PA. FDA approved Colchicine for Acute Gout on July 30,2009. Double Whammy time for Savient. But I expect them to bounce back but we will have to see.

I'm including the PR newswire article at the end of this post.


Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for KRYSTEXXA(TM)


Savient to Host Conference Call on Monday, August 3, 2009 at 8:00am

EAST BRUNSWICK, N.J., Aug. 2 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that the Company has received a complete response letter from the U.S. Food and Drug Administration (FDA) stating that the FDA can not at this time approve the Company's Biologics License Application (BLA) for KRYSTEXXA(TM) (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy.


The complete response letter from the FDA cites deficiencies with the chemistry, manufacturing and controls (CMC) section of the BLA and also provided the current draft of the proposed labeling and further guidance regarding a Risk Evaluation and Mitigation Strategy (REMS) (Medication Guide and Communication Plan). The Company intends to immediately request a meeting with the FDA to discuss and clarify the issues raised in the complete response letter. Under FDA regulations, the Company believes that this meeting is deemed a "Type A" meeting, meaning that the FDA would meet with the Company within 30 days of its receipt of the meeting request.


One of the issues raised by the FDA in the complete response letter addresses a change made by the Company in the proposed process for manufacturing KRYSTEXXA for commercial use. The FDA has concluded that the comparability data submitted for the material manufactured using the proposed commercial manufacturing process was not adequate to demonstrate that it was representative of the material used to establish the safety and efficacy of KRYSTEXXA in its Phase 3 clinical trials. The FDA stated that the Company has the option of either reverting to and validating the manufacturing process used to produce KRYSTEXXA for the Phase 3 clinical trials or conducting additional comparability clinical trials to support the use of KRYSTEXXA manufactured using the proposed commercial manufacturing process. The Company currently expects that it will seek to address this issue by reverting to and revalidating the manufacturing process used to produce KRYSTEXXA for the Phase 3 clinical trials.


The complete response letter also stated that the FDA has determined that a REMS is necessary for KRYSTEXXA consisting of:


A Medication Guide to ensure the safe and effective use of KRYSTEXXA by patients,
A Communication Plan directed to healthcare providers likely to prescribe KRYSTEXXA to support the dissemination of information about the risks of severe infusion reactions and possible anaphylaxis, the risk of severe adverse reactions in administering KRYSTEXXA to patients with glucose-6-phopshate dehydrogenase (G6PD) deficiency and major cardiovascular events, and
An Assessment Plan to monitor and assess the effectiveness of the Medication Guide and Communication Plan in communicating to patients and physicians an understanding of the risks of KRYSTEXXA treatment.


The complete response letter included additional CMC comments focused on tightening manufacturing parameters and narrowing analytical specifications associated with commercial production. The Company was also informed that its resubmission to the FDA in response to the complete response letter must include an update of safety data from all on-going studies. Additionally, the Company's drug substance manufacturer BTG-Israel has already provided a work plan to remediate observations arising from the FDA pre-approval inspection of BTG-Israel's manufacturing facility and a satisfactory inspection report is required prior to the approval of KRYSTEXXA.


"While our timeline for resubmission to the FDA is subject to a number of uncertainties, we currently believe that we can target completion of our resubmission for early 2010. We hope to have more clarity on the expected timeline after we meet with the FDA to discuss the complete response letter," stated Paul Hamelin, President of Savient Pharmaceuticals. "While we believe we have made substantial progress toward the potential final approval of KRYSTEXXA, we also have more work to do with the FDA to resolve these open issues. We are committed to work diligently to address these issues with a goal of obtaining final approval for KRYSTEXXA so we can provide this therapy to those chronic gout patients who are suffering from this crippling, debilitating disease and have no other treatment options."


The Company believes that its resubmission will respond to all of the deficiencies cited in the compete response letter and would lead to a new Prescription Drug User Fee Act expected action date of either two or six months after the date of the Company's resubmission, depending on the FDA's classification of the resubmission.


ABOUT KRYSTEXXA(TM)

KRYSTEXXA(TM) (pegloticase) is a PEGylated uricase enzyme intended for the treatment of chronic gout in patients refractory to conventional therapy. Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.

ABOUT SAVIENT PHARMACEUTICALS, INC.

Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing and marketing pharmaceutical products that target unmet medical needs in both niche and broader specialty markets. Savient has developed one product: KRYSTEXXA(TM) (pegloticase) which is a PEGylated uricase enzyme intended for the treatment of chronic gout in patients refractory to conventional therapy. Savient has exclusively licensed worldwide rights to the technology related to KRYSTEXXA, formerly referred to as Puricase(R), from Duke University and Mountain View Pharmaceuticals, Inc. Savient also manufactures and supplies Oxandrin(R) (oxandrolone tablets, USP) CIII in the U.S. Further information on Savient can be accessed by visiting: http://www.savient.com. Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc.


The previous advisory panel recommendation was found in the New York Times on June 16, 2009. The link to that article can be found at the end of this post.

The approval for Colchicine is found on the FDA's website. I've included it here.

FDA Approves Colchicine for Acute Gout, Mediterranean Fever
Agency also provides new information to physicians regarding safe use of drug
The U.S. Food and Drug Administration has approved Colcrys to treat acute flairs in patients with gout, a recurrent and painful form of arthritis, and patients with familial Mediterranean fever (FMF), an inherited inflammatory disorder. The medication’s active ingredient is colchicine, a complex compound derived from the dried seeds of a plant known as the autumn crocus or meadow saffron (Colchicum autumnale).

Colchicine has been used by healthcare practitioners for many years to treat gout but had not been approved by the FDA. The FDA has an initiative underway to bring unapproved, marketed products like colchicine under its regulatory framework. This initiative promotes the goal of assuring that all marketed drugs meet modern standards for safety, effectiveness, quality and labeling.

Physicians historically have given colchicine hourly for acute gout flares until the flare subsided or they had to stop treatment because the patient began experiencing gastrointestinal problems. A dosing study required as part of FDA approval demonstrated that one dose initially and a single additional dose after one hour was just as effective as continued hourly dosing for acute gout flares, but much less toxic. As a result, the drug is being approved for acute gout flares with the lower recommended dosing regimen.

The FDA is alerting healthcare professionals to this new dosing regimen and also warning about the potential for severe drug interactions when patients take colchicine.

The medicinal value of using colchicum was first identified in the first century A.D. and its use for treating acute gout dates back to 1810. Physicians have prescribed the medication since then. Although single-ingredient colchicine has not been approved by the FDA until now, a combination product containing colchicine and an agent that increased the excretion of uric acid in the urine was approved by the FDA in 1939.

FMF is the most common of the hereditary periodic fever syndromes and is characterized by recurrent episodes of fever, arthritis and painful inflammation of the lining layers of the lungs and abdomen. Though rare in the United States, it is more common in Mediterranean countries. Physicians have prescribed colchicine for FMF for many years based on studies showing that it reduced the frequency of attacks but use of colchicine for FMF had never been approved. With this approval, Colcrys becomes the first drug approved to treat FMF.

Colcrys is manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia.

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• When Bad News Hits, Drugmakers May See Stock Prices Fall (health.usnews.com)
• 'Disease of kings,' gout's on rise in U.S. (seattletimes.nwsource.com)
• Colchicine receives FDA approval? It's about time! (medicineandtechnology.com)

Congressional Hearing on Generics

This article was in NYT Sunday. Biologics Copyright Law coming under fire with Obama's administration. So whats the take???

Personally, I do enjoy having a job in the Biotech industry and would like to keep one in the future. With that being said, I do wish we had some type of healthcare coverage out there for people without jobs, those who can't afford it, and the elderly. But at what costs???

Already pharmaceutical companies are contemplating moving our jobs overseas and the fallout of the NC textile industry shows how quickly jobs that were once thriving in North Carolina and other parts of the country have gone elsewhere. If Obama's plan is inacted is there any assurance that our jobs won't go overseas. I see little congressional interest for this. I am worried with the State already in a deficit and close to bankrupcy how many more industry fallouts can we have in NC, tobacco, textiles, and future Biopharma industry. Or is Biopharma here to stay? We will have to see.

But how long should these companies retain copyright protection? 7-14 years is the current standard but with billions of dollars set in Research and Development of these medications is it fair to those researchers to shorten that.

Im torn because we have to fix the healthcare industry but at what price. I wish people who were sick had better options but at the same time we need jobs. This is a tough dilemna that ultimately congress will pass some law that absolutely does nothing to help the situation. It still comes down to lobbyist in Washington and those paying for the votes in Congress and the Senate. We all know that and the pharmaceutical industry is no different when it comes to special interest groups with the power and those who needs the medicine pretty much helpless in the cause.

Already the elderly are going to Canada and outside the US to get there drugs. But are generics really as safe as the real thing. I don't know but I have a feeling that there are some side effects and potency issues that are taking place that we don't know about. Lets face it people make mistakes. Biopharma is no different. But you really do see a difference in price of the generics. Why are the medicines people need so expensive and why can't the govenrnment do something that isn't going to cost us jobs that we ultimately lose someday.

So thats my take. Here's a great article on the whole news.

Also check out this good blog on generics at:
http://genericdrugs.blogs.ie/

Setting a price on life
Biotech drugs facing pressure from generics. Costly Drugs Known as Biologics Prompt Exclusivity Debate

A bitter congressional fight over the cost of super-expensive biotechnology drugs has come down to a single, hotly debated number: How many years should makers of those drugs be exempt from generic competition?

But what few people in Washington seem to recognize — or publicly acknowledge, anyway — is this magic number may ultimately not matter as much as the most vitriolic debaters insist.

At issue are such drugs as Cambridge-based Biogen Idec’s Avonex, for multiple sclerosis, which costs more than $20,000 a year; Genentech’s Avastin for cancer, which costs more than $50,000; and several Genzyme drugs for rare diseases that can cost $200,000 a year or more. Typically, such drugs are given by injection or intravenous infusions.

These drugs, known as biologics, are complex proteins made in vats of living cells. Because they are hard to copy exactly, they have not been subject to the generic competition that eventually knocks down the price of drugs such as Lipitor and Prozac. Pills such as Lipitor, known in the industry as small-molecule drugs, are made from simple chemicals whose recipes are easy to reproduce.

But now Congress, as a cost-cutting piece of the overall health care effort, is preparing legislation to enable the Food and Drug Administration to approve copycat versions of biologic drugs. That could save consumers, insurers and the government billions of dollars in the coming years.

The trick is to allow competition without undermining the financial incentives the pharmaceutical industry needs to undertake the risky job of developing the next drugs for cancer and other diseases. That is where the magic year number comes in. Trade groups for the big pharmaceutical and biotechnology companies say that to recoup their investments, they need an exclusivity period free of generic competition that would last 12 to 14 years from the time the FDA approves a drug for sale.

But consumer groups, insurers, employers and generic drug companies say anything more than five years — the exclusivity period now given to small-molecule drugs such as Lipitor — would eviscerate any potential savings from the new competition.

So far, the biotechnology industry appears to be winning. The Senate’s health committee, for example, has agreed to 12 years of exclusivity. In the House, a bill that provides at least 12 years of exclusivity has many more co-sponsors than one that would provide five years. The Obama administration has said seven years would be a “generous compromise.”

But in reality, neither the threat to innovation nor the potential savings from generic competition are as great as claimed.

For starters, whatever the exclusivity period, biologic drugs would also continue to be protected from copycats by patents. And in many cases, the patent protection would last longer than the exclusivity period, making the congressionally mandated exclusivity a moot point.

San Francisco-based Genentech’s Avastin, for instance, has patent protection until 2019 — 15 years after the drug’s 2004 approval by the FDA. The company’s breast cancer drug, Herceptin, has patents that extend 21 years from its 1998 approval.

Where the exclusivity period might matter most would be in the cases of drugs whose patents were nearing expiration by the time the developer succeeded in winning FDA approval. But that seldom happens.

“I can’t think of a biotech drug that’s been on the market that doesn’t have more than 7 to 14 years of patent protection,” said Eric Schmidt, biotechnology analyst at Cowen and Co.

Still, it is probably not true, as the other side claims, that the legislation would be virtually worthless if it granted a long exclusivity period. There are plenty of blockbuster biologics, like Amgen’s Epogen and Neupogen, that have been on the market more than 12 or 14 years and thus would get no extra protection from even an exclusivity period in the longer of the ranges now being discussed.

As for cost savings, the Congressional Budget Office has estimated that generic biologics might save the government only about $10 billion in the next 10 years. That is a relative drop in the bucket when it comes to paying for health care reform, which is expected to cost about $1 trillion over 10 years.

One reason for limited savings in the first decade is that it would probably take a few years for copycat biologics to reach the market after the law was enacted. Another factor is that biologics accounted for only 16 percent — about $46 billion — of total prescription drug spending last year, according to the market researchers IMS Health. And pharmaceuticals represent only about 10 percent of the nation’s overall health care spending.

The real savings might come more than 10 years out, as new biologic drugs appear and as biologics represent an increasingly greater part of overall spending on drugs. That ramp-up is already evident: Express Scripts, a pharmacy benefits manager, says its spending on biologics grew 10 percent last year, compared with 2.5 percent for other drugs.

But anyone expecting the price wars that ensue when generic pills come on the market — when prices often drop by more than 60 percent — might be disappointed by the way competition plays out.

Because it is harder and costlier to make biologic drugs than it is to copy pills, fewer generic competitors are likely to enter the fray. Many experts, including the Federal Trade Commission, expect price declines of more like 10 percent to 40 percent in biologics.

Even that would be a savings for the overall health care system. But for many individuals, a $35,000 copycat version of a $50,000 cancer drug would still be unaffordable.

Another factor is that generic biologics are likely to undergo greater regulatory scrutiny than generic pills require.

It is difficult or impossible to verify that a copy of a biologic is exactly the same as the original — which is why the drugs are often called “biosimilars” rather than generic biologics. Because even small changes might affect the drug’s safety or activity, it is likely that makers of biosimilars will have to conduct at least some clinical trials to win FDA approval of their drugs, which makers of generica small-molecule pills are not required to do. Such trials can cost a lot of money.

And because biosimilars will not be exact replicas of the drugs they mimic, the generic makers will probably need sales forces to persuade doctors to prescribe their drugs and pharmacists to dispense them. All of that costs money, too.

In Europe, which has already approved biosimilar versions of three biologic drugs, the market impact has been relatively small so far. In Germany, where biosimilars have made the biggest advances, the products have captured about 30 percent of the market for anemia drugs and prices have dropped only about 20 percent to 30 percent.

The likelihood that biosimilar competition might be somewhat muted means that sales and profits of the originals not necessarily dry up.

Kevin W. Sharer, Amgen’s chief executive, told investors in May that he hoped biotechnology companies would retain 30 percent to 50 percent of the cash flow from their drugs even after biosimilars reached the market. That, he said, “is a dramatically different outcome than we see in the small-molecule companies.” That is also one reason the Federal Trade Commission, in a report last month, said that no exclusivity period at all was needed. At the very least, because biologic drugs do not require appreciably more time or money to bring to market than small-molecule drugs, it is reasonable to ask why they should deserve longer protection from competition than the five years that small-molecule drugs now receive.

The reason, biotechnology executives say, has to do with patents, which may offer less protection for biologics than for small-molecule drugs. Because a biosimilar is not an exact knock-off of the original, a competitor might persuasively claim that it is not infringing the patents on the original drug.

So far biologic patents have held up well in court cases. Amgen, for example, has won legal victories preventing two separate competitors from introducing anemia drugs that were slightly different from its own Epogen.

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Teva and Boston Scientific Thursday July 15 2009

BOSTON SCIENTIFIC CP(NYSE: BSX)
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Open: 10.32
1y Target Est: 11.65
Day's Range: 10.01 - 10.32
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Avg Vol (3m): 14,615,000
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Boston Scientific Corp. said it received European approval to introduce its Latitude remote-monitoring program for heart-failure devices and defibrillators across the continent in a move that could boost the adoption of its products there.

The remote-monitoring system is already approved for use in the U.S.

Analysts say that no single U.S. player in cardiac rhythm management has advanced far beyond the others in device function, so service aspects such as remote monitoring, sometimes called telemedicine, have the potential to help differentiate the companies.

The big U.S. players in cardiac rhythm management have been expanding, even touting, their possibly cost-saving telemedicine systems, as the federal government initiates widespread health-care changes. Boston Scientific, Medtronic Inc. and St. Jude Medical Inc. offer these programs in the U.S., although Medtronic has the lion's share of the market and offers its service for pacemakers, unlike the other two.

"This is where therapy is going," said Fred Colen, president of cardiac rhythm management for Boston Scientific. "Remote monitoring for patients, for any condition, is on the rise."

Boston Scientfic said it earned CE-mark approval, which certifies that the product meets consumer-safety and health standards in Europe, where the market for heart-failure devices and defibrillators is estimated to be around $1.5 billion.

So far, the Latitude program has been used for patients in the Netherlands and Denmark, and the company hopes to expand to 14 European Union countries in a phased approach.

Keay Nakae, an analyst with Collins Stewart LLC, said the company's recent U.S. growth hasn't been mirrored in Europe. Among the reasons is the lack of a monitoring system. The system "isn't a primary reason you'd use one device," he said. "But having it as a function and a capability is certainly a positive."

Telemedicine allows doctors to monitor their patients without in-office appointments and to intervene early if they see problems. This has the potential to reduce hospital visits and length of stays, though no company has completed clinical studies on the effect. Analyst Jan David Wald of Noble Financial said it will be helpful as the government begins to focus on medical cost efficiency.

"I think remote monitoring helps," he said. "On net, you're going to decrease the cost of health care."

The yearly cost of patient rehospitalization for congestive heart failure in the U.S. is estimated to be close to $10 billion, according to the West Wireless Health Institute, a research organization for wireless health technology.

The companies' services are included with the charge for the heart devices, and there is no monthly charge for patients. Doctors are reimbursed by insurance or Medicare for remote monitoring checkups as well.

Each company offers different amenities with its devices. For example, Medtronic's system monitors fluid levels automatically. Boston Scientific's system can monitor patients' weight and blood pressure. St. Jude plans to use its system for its pacemakers, pending Food and Drug Administration approval for the devices, and Boston Scientific plans to use it in its next generation of pacemakers, company representatives said.

Collins Stewart's Mr. Nakae thinks that telemedicine is more of a necessity than a bonus for the companies.

"I think it's something that everybody wants to have, and if you don't have it in the bigger picture, you could be at a disadvantage," he said.



Teva Pharma Plan B Approved by the FDA

Teva Pharmaceutical Industries (NasdaqGS: TEVA)
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Volume: 4,219,948
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WASHINGTON -- The Food and Drug Administration approved labeling
that will allow 17-year-olds access to the Plan B emergency-contraceptive pill
without a prescription.The agency also approved a one-dose version of the product called Plan B One-Step that will also be available over-the-counter to women age 17 and older. Both products are sold by Duramed Pharmaceuticals, a unit of Teva
Pharmaceuticals Industries Ltd.

Duramed loses market exclusivity on the traditional Plan B pill -- which is
taken in two steps -- next month, allowing generic versions to be made available.
Teva said the Plan B One-Step would be available in pharmacies next month. In March a federal court ordered the FDA to lower the age requirement set by the Bush administration for Plan B to be sold over-the-counter from 18 to 17.

In 2006, the FDA agreed to make Plan B available without a prescription to
women over 18 and required the product to be placed behind the pharmacy counter. In 2004, the FDA rejected an application to make Plan B available without a prescription even though an advisory panel of outside medical experts voted to support the switch from prescription to non-prescription status.

Plan B was approved as a prescription "emergency" contraceptive in 1999. It is
made of the hormone progestin, and is designed to prevent pregnancy if taken
within 72 hours of unprotected sexual intercourse. The original Plan B pill is designed to be taken in two doses 12 hours apart.

The pills are similar to birth-control pills but contain higher doses of
progestin to block a potentially fertilized egg from becoming implanted in a
woman's uterus.The court ruling came in response to a lawsuit filed in 2005 by the Center for Reproductive Rights, a women's health advocacy group.

Big Day For Eli Lilly LLY

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Lilly Receives Fourth FDA Approval for ALIMTA(R) (pemetrexed for injection)

Eli Lilly and Company logo. (PRNewsFoto)

INDIANAPOLIS, IN UNITED STATES


ALIMTA First Chemotherapy Approved As Maintenance Therapy For Nonsquamous Non-Small Cell Lung Cancer

INDIANAPOLIS, July 6 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) announced today it received a fourth approval from the U.S. Food and Drug Administration (FDA) for ALIMTA(R) (pemetrexed for injection). The latest approval is for ALIMTA as a maintenance therapy for locally advanced or metastatic non-small cell lung cancer (NSCLC), specifically for patients with a nonsquamous histology whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ALIMTA is not indicated for treatment of patients with squamous cell non-small cell lung cancer.

NSCLC is the most common form of lung cancer, resulting in more than 180,000 new cases in the U.S. each year.(1),(2) It is defined as a group of histologies, that is, tumor types differentiated by cellular structure. Nonsquamous histology includes adenocarcinoma and large cell carcinoma, which account for more than half of all NSCLC diagnoses,(3) as well as histologies classified as "other."

"This FDA approval is encouraging news for non-small cell lung cancer patients, their caregivers and doctors," said Richard Gaynor, M.D., vice president of cancer research and global oncology platform leader for Lilly. "It represents an important paradigm shift for NSCLC treatment - maintenance therapy as a way of extending survival in nonsquamous patients, using histology as a way of determining which NSCLC patients may benefit and which may not.

"Previously, patients received best supportive care following their chemotherapy. Now physicians and patients have a new option to improve survival," added Gaynor.

The notion of maintenance therapy in NSCLC is new. Maintenance therapy is treatment given after initial chemotherapy but before new tumor growth. And while pathologists routinely determine the cancer's histology, or tissue type, the use of this information to tailor therapy for potentially better outcomes is also new.


Results from a global, multicenter, double-blind Phase III trial were presented as an oral presentation at the American Society of Clinical Oncology (ASCO) annual meeting in Orlando, Fla. on May 31, 2009 (Abstract # CRA8000) by Chandra Belani, M.D., Miriam Beckner distinguished professor of medicine and deputy director of Penn State Cancer Institute at Penn State Milton S. Hershey Medical Center.


The trial compared efficacy with respect to overall survival of ALIMTA plus best supportive care versus placebo plus best supportive care in 663 patients with stage IIIB/IV NSCLC whose disease had not progressed after four cycles of platinum-based induction chemotherapy. The trial supported previous studies looking at the use of histology to tailor treatment for patients with advanced nonsquamous NSCLC.


Patients in the trial were treated with ALIMTA (500 mg/m2 on day one of each 21-day cycle) plus best supportive care or placebo plus best supportive care. All patients were supplemented with vitamin B12, folic acid and dexamethasone.


In 2004, ALIMTA received consecutive approvals: it was the first agent to be approved in combination with cisplatin as a treatment for patients with malignant pleural mesothelioma, whose disease is unresectable or who are otherwise not candidates for curative surgery, and then as a single agent for the second-line treatment of patients with locally advanced or metastatic NSCLC after prior chemotherapy treatment.(4)


In 2008, ALIMTA, in combination with cisplatin, was approved as a first-line treatment for locally advanced or metastatic NSCLC for patients with nonsquamous histology. At the time of the first-line approval, the FDA also approved a change to the second-line indication. ALIMTA is now indicated as a single agent for the treatment of patients with locally advanced or metastatic, nonsquamous NSCLC after prior chemotherapy. ALIMTA is not indicated for treatment of patients with squamous cell non-small cell lung cancer.

For full prescribing and safety information about ALIMTA, visit www.ALIMTA.com.


Notes to Editor

About Non-Small Cell Lung Cancer (NSCLC)


NSCLC is the most common type of lung cancer and represents 85 to 90 percent of all lung cancers.(5) NSCLC has five-tier staging, starting at 0 and rising to the severity of stage IV.(6) NSCLC can spread through the lymphatic system, penetrating the chest lining, ribs, and the nerves and blood vessels that lead to the arm. The liver, bones and brain are potential targets if the cancerous cells enter the bloodstream.

According to the World Health Organization (WHO) Cancer Report, lung cancer is the world's most common cancer and the leading cause of cancer death for men and women. More than 1 million people die from lung cancer each year.(7)

About Lilly Oncology

For more than four decades, Lilly has been dedicated to delivering innovative solutions that improve the care of people living with cancer. Because no two cancer patients are alike, Lilly Oncology is committed to developing novel treatment approaches. To learn more about Lilly's commitment to cancer, please visit www.LillyOncology.com.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.

ALIMTA(R) (pemetrexed for injection), Lilly

() American Cancer Society, "What Is Non-Small Cell Lung Cancer?," October 15, 2007, American Cancer Society, http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Non-Small_Cell_Lung_Cancer.asp?rnav=cri, (February 21, 2008).

(2) American Cancer Society, "What Are the Key Statistics About Lung Cancer?," October 15, 2007, American Cancer Society, http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Are_the_Key_Statistics_About_Lung_Cancer_15.asp?rnav=cri, (September 19, 2008).

(3) American Cancer Society. What is Non-Small Cell Lung Cancer? Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Non-Small_Cell_Lung_Cancer.asp?sitearea=. Accessed May 1, 2009.

(4) NOTE: The 2nd-line NSCLC indication was approved under 21 CFR 314.500 et seq (Subpart H - Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses) using a surrogate endpoint.

(5) American Cancer Society, "What Is Non-Small Cell Lung Cancer?," October 15, 2007, American Cancer Society, http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Is_Non-Small_Cell_Lung_Cancer.asp?rnav=cri, (February 21, 2008).

(6) American Cancer Society, "How Is Non-Small Cell Lung Cancer Staged?" October 15, 2007, American Cancer Society, www.cancer.org/docroot/CRI/content/CRI_2_4_3x_How_Is_Non-Small_Cell_Lung_Cancer_Staged.asp?rnav=cri, (February 21, 2008).

(7) World Health Organization, Gender in Lung Cancer and Smoking Research, Department of Gender, Women and Health, 2003, http://www.who.int/gender/documents/en/lungcancerlow.pdf.