Dr Reddy’s faces a deadlock on generic lenalidomide launch in US as Celgene refuses to supply Revlimid samples

Celgene tries to block Dr Reddy’s Revlimid generic using REMS as an excuse, say reports.

India’s Dr Reddy’s is facing an unexpected but major hurdle on its course to launch a generic version of Revlimid in US as Celgene refuses to make the brand name drug samples available for bio equivalence studies for the company.

Hyderabad, south India-based Dr Reddy’s approached Celgene to purchase Revlimid samples to conduct the USFDA mandated bio-equivalence studies before seeking approval for a prospective generic version of Celgene’s blood cancer drug.

Dr Reddy’s directly wrote to Celgene for the bio samples because Revlimid is not available through normal distribution channels. However, Celgene has been refusing Dr Reddy’s repeated request for the purchase of Revlimid bio samples saying that the company “is under no obligation to supply” the samples to Dr Reddy’s.

Revlimid therapy is known to cause certain birth defects in human if taken during pregnancy. So Revlimid is currently placed under US FDA’s Risk Evaluation and Mitigation Strategy (REMS).

Hence Dr Reddy’s cannot legally purchase the required quality of Revlimid from the market but has to obtain directly from Celgene.

Celgene is apparently using REMS as an excuse to stop Dr Reddy’s from launching the generic version of Revlimid, reports said.

Now Dr Reddy’s has appealed US FDA to spell out policy to assure that new REMS will be used to block generics.

In its petition to US FDA filed in June, Dr Reddy’s argued that Celegene is using REMS restrictions to “block or delay generic competition”.

“A company can tie-up the supply of a REMS-restricted distribution drug product thereby forcing a generic manufacturer to find alternative means …. This is done to allege later (when the generic company has procured the drug from other sources) that it has been done unlawfully. This practice is anti-competitive,” said Dr Reddy’s, in the petition.

The new REMS authority was given to FDA in 2007 .The law known as the FDA Amendments Act (FDAAA) allows FDA to require a Risk Evaluation and Mitigation Strategy (REMS) for drugs associated with greater safety risks. But the law states unequivocally that restricted distribution programmes are not to be used to block or delay generic competition.

On an earlier occasion also, Celgene declined to supply samples to another generic drug maker Barr Pharma when it wanted to procure Thalomid.
Revlimid contains lenalidomide, a derivative of thalidomide. Revlimid (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy.Revlimid was introduced in 2004.

Revlimid (lenalidomide) received U.S. Food and Drug Administration (FDA) on June 29, 2006.

On 23 April 2009, the National Institute for Health and Clinical Excellence (NICE) has issued a Final Appraisal Determination (FAD) approving lenalidomide, in combination with dexamethasone, as an option to treat patients who suffer from multiple myeloma.

Revlimid is also approved in nearly 50 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

Revlimed is also approved in the United States, Canada and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Marketing Authorisation Applications are currently being evaluated in a number of other countries.

Celgene International Sàrl filed a New Drug Application (NDA) with the Japanese Ministry of Health, Labour and Welfare (MHLW) for Revlimid (lenalidomide) in combination with dexamethasone for the treatment of patients with multiple myeloma in July this year.

Revlimid cloacked annual sales of over $1.3 billion in 2008 and is forecasted to grow by at least 20% in 2009.

Multiple myloma

Multiple myeloma also known as myeloma or plasma cell myeloma is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease.

Most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system.

Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumors. The cause of the disease remains unknown.