Top Performing Drug of 2021 - Revlimid (June Edition)

Active Ingredients: Lenalidomide

Strength: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg

Dosage Form: Capsules

Mechanism of Action: Angiogenic inhibitor

First Approval: US (Dec 27, 2005), EU (14 Jun, 2007)

Revenue

Revlimid (lenalidomide) is one of the key products of Bristol-Myers Squibb (BMS) that represent a significant percentage of the company’s total revenue. Sales of Revlimid, which was inherited through the 2019 acquisition of Celgene increased by 6% in 2021 and 23% in 2020. The U.S. revenues increased 5% in 2021 due to higher average net selling prices and higher demand. International revenues increased 8% in 2021 due to higher demand and foreign exchange impacts. Let’s see in what manner the revenue of Revlimid changes over the last five years.¹

Approved Indications for Revlimid²

Revlimid is approved and marketed in the US and Europe for various indications including:

Multiple Myeloma: In combination with dexamethasone is indicated for the treatment of patients with multiple myeloma (MM) who have received at least one prior therapy.

Multiple Myeloma, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT).

Myelodysplastic Syndromes: Patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Mantle Cell Lymphoma: Patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
Follicular Lymphoma: Previously treated follicular lymphoma (FL), in combination with a rituximab product.

Clinical Trials³

Revlimid has a total of 1009 trials which included 643 industry trials of which 598 were interventional, 40 observational & 5 expanded access trials. From the analysis of clinical trials, we have made a representation for the trials of Revlimid. (Trials are taken as of 16 Jun 2022).

Active trials include Recruiting; Active, Not Recruiting; Enrolling by Invitation, and suspended

*Inactive trials include Terminated; Withdrawn; Unknown Status

*Planned trials include Not yet recruiting

Co-Pay and Financial Assistance⁴

BMS Access Support helps identify financial assistance programs for eligible patients who have been prescribed REVLIMID.

Patients With Commercial (Private) Insurance

The BMS Oncology Co-Pay Assistance Program helps commercially insured patients who have been prescribed select BMS medications with out-of-pocket deductibles, co-pays, or co-insurance requirements. Eligible patients may pay as little as $0 per one-month supply, up to a maximum of $15,000 per calendar year.

Patients With Insurance Through Federal Healthcare Programs

Patients insured through Federal Healthcare Programs are not eligible for co-pay assistance programs sponsored by Bristol Myers Squibb.

BMS Access Support can make a referral to independent charitable foundations offering support for specific patients.

Patients Without Prescription Drug Coverage or Who Are Underinsured

For patients without prescription drug insurance or for patients who are underinsured, BMS Access Support can make a referral to independent charitable foundations that may be able to help.

Please visit the Cost and Access section on www.revlimid.com and https://www.bmsaccesssupport.bmscustomerconnect.com/

Revlimid Pipeline Analysis

Various trials are ongoing for other indications. This can be categorized as follows⁵:

Other Information:⁶

Patents are a key determinant of market exclusivity for most branded pharmaceuticals. Patents provide the innovator with the right to exclude others from practicing an invention related to medicine. Revlimid is one of the important revenue driver drugs for BMS. The company has settled various patent litigations for Revlimid.

Revlimid has 377 international patents, 15 US patents, and 566 patent applications.

Revlimid Generic⁷

A generic version of Revlimid manufactured by Teva Pharmaceuticals was approved by the Food and Drug Administration (FDA) with dosages available at 5mg, 10mg, 15mg, and 25mg capsules. In terms of safety, quality, performance characteristics, and intended use, generic Revlimid is the same as the marketed brand-name drug manufactured by Bristol Myers Squibb. Generic Revlimid can be used as a substitute for Revlimid.

References:

1. https://d18rn0p25nwr6d.cloudfront.net/CIK-0000014272/f4a6942f-7e0d-4d3e-9ef4-b3b0a9d617d7.pdf

https://d18rn0p25nwr6d.cloudfront.net/CIK-0000014272/3ce77643-0766-432d-9e59-7fd68f871d4a.pdf

https://d18rn0p25nwr6d.cloudfront.net/CIK-0000014272/468bfaba-6810-4cec-80b5-94aa4c7a5a23.pdf

https://www.sec.gov/Archives/edgar/data/0000816284/000081628419000014/a2018123110-k.htm

https://www.sec.gov/Archives/edgar/data/0000816284/000081628418000005/a2017123110k.htm

2. https://packageinserts.bms.com/pi/pi_revlimid.pdf

3. https://clinicaltrials.gov/ct2/results?cond=&term=revlimid&cntry=&state=&city=&dist=

4. https://www.revlimid.com/cost-access

5.https://clinicaltrials.gov/ct2/show/NCT01749969?term=revlimid&recrs=bdf&type=Intr&phase=0&fund=2&draw=2&rank=1

https://clinicaltrials.gov/ct2/show/NCT05222555?term=revlimid&recrs=bdf&type=Intr&phase=0&fund=2&draw=2&rank=7

https://clinicaltrials.gov/ct2/show/NCT03701711?term=revlimid&recrs=bdf&type=Intr&phase=0&fund=2&draw=2&rank=8