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Celgene: Revlimid shows promise on two fronts

Celgene has submitted a new drug application to the FDA for MDS.

April 11, 2005 6:01 PM GMT (Datamonitor) - Clinical data from Celgene's Phase II trial has formed the basis for a rolling NDA for the treatment of MDS with 5q chromosomal abnormalities. Celgene's growing reputation in the oncology franchise suggests that Revlimid has good opportunity to realize commercialization. However, Revlimid will face stiff competition from other novel agents submitted to the FDA for the same indication.

Initial results in preliminary trials for myelodysplastic syndromes (MDS) have demonstrated that transfusion independence was achieved in 64% of patients. Completed results from this trial have formed the basis of the NDA. According to the American Cancer Society, 10,000 to 20,000 new MDS cases are diagnosed each year in the US.

MDS patients frequently become transfusion dependant to manage the accompanying anemia and fatigue. The condition has previously been described as a pre-leukemia, with approximately 30% of sufferers going on to develop acute myeloid leukemia. As such, MDS patients represent a clinically underserved population where agents that reduce transfusion dependence and prevent or delay progression to AML are required.

Revlimid (lenalidomide) belongs to a new class of novel immunomodulatory drugs, or IMiDs, which exert their anti tumor properties by modulation of tumor necrosis factor alpha. Revlimid is a derivative of Celgene's flagship product, thalidomide. Revlimid has been demonstrated to be more potent than thalidomide in multiple myeloma ] and has a much improved toxicity profile. Notably, Revlimid does not have the devastating teratogenic effects of thalidomide.

Celgene has no approved marketed oncology products, though thalidomide's off-label use in multiple myeloma will have given Celgene some degree of experience in the oncology field. Revlimid's favorable clinical activity and reduced toxicity, combined with the convenience of one-daily oral administration and Celgene's growing reputation in the multiple myeloma franchise, suggest that Revlimid has good opportunity to realize commercialization. Two Phase III trials examining Revlimid in multiple myeloma were halted early due to both trials exceeding their primary end point, time to progression. Revlimid will benefit from Orphan Drug Status which has been awarded for both indications.

There are no approved IMiDs at present and there remain, therefore, a number of regulatory and marketing hurdles for Celgene to clear before Revlimid could gain approval. Given these circumstances Revlimid will face stiff competition from other therapies in both markets. Within the multiple myeloma market a range of rival novel therapies will compete with Revlimid, such as Millennium Pharmaceuticals' already-approved Velcade (bortezomib) and, within MDS, MGI Pharma's Dacogen (decitabine).

Lemonade for Leukemia

Lemonade stand will help leukemia victims

NORTH PORT - 05/27/05 - If Greggory Malak had $500, he would donate it all for a worthy cause. Instead, all the 9-year-old had was a batch of lemons.

Malak, Glenallen Elementary School student in North Port, decided he could crush lemons, make lots of lemonade and earn the $500 this weekend so he can donate the money Leukemia Foundation.

Malak knew he wasn't old enough to work a regular 8-to-5 job to earn the money. So, he asked his mom and dad for help to complete his goal.

Malak's parents Mary and Rob, owners of Serendipity, a full-service restaurant inside of Treasure Lanes Bowling Center in Murdock, encouraged Greggory to following his dream.

During the school year, Greggory came home from Glenallen with a notice that the school was sponsoring a fund-raiser for the Leukemia Foundation. In addition to the school's efforts, Greggory wanted to do something extra special to help the Leukemia Foundation.

"That's when I wanted to do a Lemonade for Leukemia stand," said Greggory. "What better way to kick off the summer than with a cold glass of lemonade."

Rob said he not only wanted to assist his son raise the money, but had another personal interest in helping.

"My brother died a few years ago from leukemia," Rob said. "The worst part was that we were helpless. I think that is the hardest part for family members. It may be too late for my brother, maybe with the donations from the lemonade stand we can be of help to others who still have a chance."

Mary also wanted to do her part for Greggory. She called Pepsi asking if they would contribute something to the fund-raiser.

"They responded immediately allowing us whatever products we needed for the lemonade stand," she said smiling. "This was wonderful."

As soon as the Malak's received the green light, Rob began building the lemonade stand with Greggory and Leo assisting with the signs.

Greggory will be working the stand beginning at 9 a.m. Saturday through the weekend -- straight through Memorial Day afternoon. He will be encouraging children and adults of all ages to buy a glass of lemonade for a "good cause and for the great taste."

The Leukemia Foundation helps leukemia victims with their Make a Dream Come True program (granting wishes to any child with a life-threatening disease anywhere in the country, offers stem cell banking (collection and freezing of blood from babies' umbilical cords replaces the frightening and discouraging search for a bone marrow donor), does bone marrow searches, offers patient advocacy, volunteer programs, fund-raising and education. It is one of the leading non-profit organizations in the fight against leukemia and cancer for children and adults. The organization's main objective is to provide the cure for children and adults, and to ease the family's burden during their hospital stay. We can't achieve our goal without your assistance.

"I know it might sound funny to come to the bowling alley just for a glass of lemonade, but we sure hope people will stop in because they care," said Mary. "I'm glad my son found something close to his heart and wants to help."

For more information, call Mary Malak at Serendipity at 627-0076.

You can e-mail Elaine Allen-Emrich at [email protected].

By ELAINE ALLEN-EMRICH

North Port Assistant Editor

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