FDA Gives OK To Wyeth’s Pristiq

The U.S. Food And Drug Administration has approved Wyeth’s new antidepressant Pristiq.

Pristiq is the successor to Effexor, which accounted for about seventeen percent of Wyeth’s total revenue with sales of $3.8 billion. 

Since generics are expected to chip into that profit margin, a new antidepressant with the benefit of patent protection will certainly help the company’s bottom line.

It’s not the end of the line for FDA evaluation, however.  Approval was conditional on the drugmaker agreeing to multiple post-marketing commitments, which will include submission of data from multiple studies.

“PRISTIQ is an important new therapeutic option for patients and clinicians because no single therapy works for all people with major depression,” said Philip Ninan, M.D., Vice President of Wyeth Medical Affairs, Neuroscience.

“PRISTIQ is approved at a once-daily 50-mg dose that does not require titration, allowing physicians to start their patients at the recommended therapeutic dose. We are encouraged by the tolerability profile seen in clinical studies.”

Celgene Picks Up Pharmion For A Cool $2.9 Bill

Celgene Corporation and Pharmion Corporation today jointly announced the signing of a definitive merger agreement pursuant to which Celgene has agreed to acquire Pharmion. Under the terms of the merger agreement, Celgene will acquire all of the outstanding shares of Pharmion common stock for $72.00 per share payable in a combination of cash and shares of Celgene common stock. The transaction is expected to be slightly dilutive to earnings in 2008 and accretive in 2009 and beyond.

The acquisition of Pharmion furthers Celgene’s strategy to become a global leader in the hematology/oncology field. The transaction brings together three medically meaningful therapies, Revlimid(R), Thalomid(R) and Vidaza(R), treating different patient populations worldwide. These products are expected to generate multiple global revenue streams for accelerated revenue and earnings growth over the next five years.

“The acquisition of Pharmion is an exceptional strategic fit that will expand our role as a leader in hematology and oncology,” said Sol J. Barer, PhD, Chairman and Chief Executive Officer of Celgene Corporation. “Our combined global infrastructure will leverage the therapeutic and commercial potential of Pharmion’s products, particularly Vidaza, which has the potential to become a major global therapy. By bringing together the talents and resources of both companies, we move closer to our vision of becoming a leading hematology and oncology company in the world, expanding our industry leading programs for safety, access and patient support.”

Pharmion is a global drug development company that has built a successful and promising oncology franchise. Pharmion has four products on the market and several in development focused on hematological and solid tumor cancers. Vidaza is approved in the U.S. for myelodysplastic syndromes (MDS). Vidaza has demonstrated unprecedented overall survival benefit for higher-risk MDS patients based on a Phase III trial. Pharmion previously reported that its Phase III study demonstrated that Vidaza extended overall survival by 74 percent as compared to conventional care regimens. Patients receiving Vidaza had a two-year survival rate of 50.8 percent versus 26.2 percent for those in the comparator arm. These results translated into a median survival benefit of 9.4 months (24.4 months versus 15.0 months). Pharmion expects to file a Market Authorization Application (MAA) in Europe for Vidaza in higher-risk MDS before the end of the year.

Additionally, thalidomide (licensed to Pharmion by Celgene to develop and commercialize in Europe and other select countries) is under review by the European Medicines Agency (EMEA) as a therapy in newly diagnosed multiple myeloma. An EMEA action is expected in late 2007 to early 2008. Pharmion’s clinical development pipeline includes Amrubicin, a third generation synthetic anthracycline, which is in Phase III development for the treatment of small-cell lung cancer (SCLC) under an approved Special Protocol Assessment (SPA). MGCD0103, a selective histone deacetylase (HDAC) inhibitor is being evaluated in Phase II studies in hematological malignancies as well as in solid tumors.

“The combination of our two product portfolios and organizations represents the opportunity to create a leading global hematology/oncology company,” said Patrick J. Mahaffy, President and Chief Executive Officer of Pharmion Corporation. “In particular, I would like to thank the Pharmion employees who have contributed so much to the development of our company and to ensuring that our products are available to improve the lives of cancer patients in the US, Europe, and many international markets. We believe that Celgene is now exceptionally well positioned to take advantage of these efforts, as well as those of its own strong organization, to create a truly unique global biopharmaceutical company.”

Terms of the Transaction

The transaction has been unanimously approved by the Boards of Directors of both companies and is subject to customary closing conditions including the approval of the acquisition by stockholders of Pharmion and receipt of antitrust clearances. Celgene and Pharmion expect the transaction to close by the end of the second quarter of 2008. Under the terms of the merger agreement, each share of Pharmion common stock will be exchanged for $25.00 in cash and shares of Celgene common stock in an amount to be determined by an exchange ratio. If the volume weighted average price per share of Celgene common stock for the 15 consecutive trading days ending on (and including) the third trading day immediately prior to the closing date of the merger (the “VWAP Closing Price”) is between $56.15 and $72.93, then the exchange ratio will be equal to $47.00 divided by the VWAP Closing Price. If the VWAP Closing Price is less than $56.15, Pharmion stockholders will receive 0.8370 Celgene shares for each share of Pharmion common stock, and if the VWAP Closing Price is greater than $72.93, Pharmion stockholders will receive 0.6445 Celgene shares for each share of Pharmion common stock. The cash portion of the transaction is being funded by Celgene’s cash on hand. Upon the closing of the acquisition, Pharmion stockholders will own approximately six percent of Celgene’s outstanding common stock.

Source: Celgene

Consumers Union: Prepare For Medicare Drug Plan Hikes

Halloween may be over, but Medicare Part D beneficiaries shopping during open enrollment could be in for a nasty scare, with up to $1,915 in cost increases next year for premiums and five commonly used prescriptions — the equivalent of about two month’s worth of Social Security checks.

“Anyone currently enrolled in the Medicare drug program should sit down with their family this holiday season to make sure their plan still offers a good deal next year,” said Bill Vaughan, senior health policy analyst for Consumers Union.

“Those folks who simply stick with their current drug plan and fail to check next year’s prices and premiums could face financial disaster come January,” Vaughan added.

Consumers Union also found that while many plans are reducing monthly premiums for next year, they actually are increasing overall annual costs for a theoretical basket of five common prescription drugs monitored in the study.

“Lower monthly premiums can be dangerously deceptive to a senior who doesn’t also check on the costs of the drugs they are taking under that plan,” Vaughan said. “Just because you see your monthly premiums go down, don’t assume your drug costs won’t go up, perhaps dramatically.”

In zip codes in five states (New York, Illinois, California, Texas and Florida), Consumers Union compared January 2007 Medicare Part D Plan out-of-pocket prices for five common drugs(1) and monthly premiums with those advertised for January 2008. At least 82 percent of plans in each state increased their overall costs(2), and out of the total 247 plans, 39 plans, or 16 percent, increased their costs by 25 percent or more(3).

The largest increase among the five states sampled was for Envision RxPlus Gold of New York, which increased total premium and drug costs 60 percent(4) - or $1,915 - from January 2007 to January 2008. This plan also had the highest increases in Florida and California, and Texas (along with Blue MedicareRx Standard), and was second only to Blue MedicareRx Standard in Illinois.

“It is so important to take the time and shop among plans, and use the Medicare website (www.Medicare.gov) to check your drug costs,” Vaughan said, adding that CU found up to a $2,700 difference between the lowest and highest cost plan within a state for the five drugs sampled. “A plan that was a bargain this year may be the exact opposite next year. Beneficiaries have just a few weeks during open enrollment to avoid being stuck with a high cost plan in 2008.”

While the majority of plans CU sampled increased overall costs, some plans kept costs low, or even reduced their costs from year to year.

In 2007, HealthSpring Prescription Drug Plan-Reg 22 had the fifth lowest overall drug costs of any plan in Texas for the five sampled drugs and premiums, and a 2008 cost increase of as little as 3 percent(5). This now makes it the least expensive plan in the state for the five drugs (in New York, Illinois and California the least expensive plans for these five drugs are also run by HealthSpring).

“It is essential that beneficiaries look carefully on the Medicare website and in the ‘Medicare and You Handbook’ for plans with prices that start low and stay low,” Vaughan said.

Consumers Union also reminds beneficiaries that many could benefit by reviewing their drug options with their doctors and considering effective, lower-cost alternatives. Savings from moving to a generic or lower cost brand alternative might more than cover their Part D premiums. Information on the safest, most effective drugs is available, free, on the CU website, www.CRBestBuyDrugs.org.

Source: Consumers Union

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