Biotech

Cipla licensed to sell volume-limited amounts of generic lenalidomide in the U.S. beginning on a confidential date after March 2022

Cipla also licensed to sell generic lenalidomide in the U.S. without volume limitation no earlier than January 31, 2026

The earliest licensed entry of any generic lenalidomide in the U.S. continues to be March 2022, based on settlements reached

Bristol Myers Squibb (NYSE: BMY) today announced that its wholly owned subsidiary, Celgene, and Cipla Limited (Cipla) have settled their litigation related to patents for REVLIMID ® (lenalidomide).

As part of the settlement, the parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin Cipla from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement, as described below.

In settlement of all outstanding claims in the litigation, Celgene has agreed to provide Cipla with a license to Celgene's patents required to manufacture and sell certain volume-limited amounts of generic lenalidomide in the United States beginning on a confidential date that is some time after March 2022. For each consecutive twelve-month period (or part thereof), following the volume-limited entry date until January 31, 2026, the volume of generic lenalidomide sold by Cipla cannot exceed certain agreed-upon percentages. The specific volume-limited license date and percentages are confidential. In addition, Celgene has agreed to provide Cipla with a license to Celgene's patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the United States beginning no earlier than January 31, 2026.

Cipla's ability to market lenalidomide in the U.S. will be contingent on its obtaining approval of an Abbreviated New Drug Application.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , Twitter , YouTube , Facebook and Instagram .

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol Myers Squibb company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

About REVLIMID ®

In the U.S., REVLIMID ® (lenalidomide) in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma. REVLIMID ® as a single agent is also indicated as a maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant. REVLIMID ® is indicated for patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID ® is approved in the U.S. for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Limitations of Use: REVLIMID ® is not indicated and is not recommended for the treatment of chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

Cautionary and Forward-Looking Statement

This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

Corporatefinancial-news

Bristol Myers Squibb

Media:
media@bms.com

Investor Relations:

Tim Power
609-252-7509
timothy.power@bms.com

Nina Goworek
908-673-9711
nina.goworek@bms.com

News Provided by Business Wire via QuoteMedia

Gilead Sciences Announces Second Quarter 2022 Financial Results

Biktarvy Sales Increased 28% Year-Over-Year to $2.6 billion

Oncology Sales Increased 71% Year-Over-Year to $527 million

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Aptose Reports Results for the Second Quarter 2022

─ HM43239 Preliminary Response Rate of 43% Among R/R AML Patients with FLT3 Mutations Who Failed Prior Therapy with FLT3 inhibitors ─

─ HM43239 Complete Remissions and Safety Across Three Dose Levels and Multiple Genotypic Subpopulations ─

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

AMGEN TO WEBCAST INVESTOR MEETING AT WCLC 2022

Amgen (NASDAQ: AMGN) will host a webcast call for the investment community in conjunction with the International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (WCLC) at 12:00 p.m. ET on Monday Aug. 8, 2022. David M. Reese M.D., executive vice president of Research and Development at Amgen, along with members of Amgen's clinical development team, will discuss the data being presented on LUMAKRAS ® (sotorasib) in combination with immunotherapy and in combination with a SHP2 inhibitor in non-small cell lung cancer, as well as tarlatamab data in small cell lung cancer.

The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Sosei Heptares and AbbVie Enter New Multi-target Collaboration to Discover, Develop and Commercialize Novel Medicines Targeting Neurological Diseases

  • New strategic collaboration leverages Sosei Heptares' StaR ® technology and SBDD platform and AbbVie's extensive neuroscience expertise
  • Second collaboration with AbbVie follows 2020 agreement focused on inflammatory and autoimmune diseases
  • Sosei Heptares eligible to receive up to $80 million in upfront and near-term milestone payments and has potential to receive further downstream payments totalling up to US$1.2 billion, plus tiered royalties

Sosei Group Corporation ("the Company"; TSE: 4565) and ABBVie (NYSE: ABBV), a research-based global biopharmaceutical company, announce they have entered a new drug discovery collaboration and option-to-license agreement to discover, develop and commercialize small molecules that modulate novel G protein-coupled receptor (GPCR) targets associated with neurological disease.

The new agreement will leverage Sosei Heptares' StaR ® technology and structure-based drug design (SBDD) platform and AbbVie's extensive neuroscience and disease area expertise. The agreement expands the breadth of the ongoing collaboration between Sosei Heptares and AbbVie, building on the first multi-target discovery agreement signed between the companies in June 2020, which is focused on the inflammatory and autoimmune disease areas.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

AMGEN ANNOUNCES WEBCAST OF 2022 SECOND QUARTER FINANCIAL RESULTS

Amgen (NASDAQ:AMGN) today announced that it will report its second quarter financial results on Thursday, August 4, 2022 after the close of the U.S. financial markets. The announcement will be followed by a conference call with the investment community at 2:00 p.m. PT . Participating in the call from Amgen will be Robert A. Bradway chairman and chief executive officer, and other members of Amgen's senior management team.

Live audio of the conference call will be simultaneously broadcast over the internet and will be available to members of the news media, investors and the general public.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

AbbVie Reports Second-Quarter 2022 Financial Results

  • Reports Second-Quarter Diluted EPS of $0.51 on a GAAP Basis, an Increase of 21.4 Percent; Adjusted Diluted EPS of $3.37 , an Increase of 11.2 Percent; These Results Include an Unfavorable Impact of $0.14 Per Share related to Acquired IPR&D and Milestones Expense 1
  • Delivers Second-Quarter Net Revenues of $14.583 Billion , an Increase of 4.5 Percent on a Reported Basis and 6.1 Percent Operationally
  • Second-Quarter Global Net Revenues from the Immunology Portfolio Were $7.207 Billion , an Increase of 17.8 Percent on a Reported Basis, or 19.2 Percent on an Operational Basis; U.S. Humira Net Revenues Were $4.664 Billion , an Increase of 9.6 Percent; Internationally, Humira Net Revenues Were $699 Million , a Decrease of 13.8 Percent on a Reported Basis, or 7.3 Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.252 Billion ; Global Rinvoq Net Revenues Were $592 Million ; Combined Global Skyrizi and Rinvoq Net Revenues Were $1.844 Billion
  • Second-Quarter Global Net Revenues from the Hematologic Oncology Portfolio Were $1.650 Billion , a Decrease of 9.1 Percent on a Reported Basis, or 7.9 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $1.145 Billion , a Decrease of 17.1 Percent , with U.S. Net Revenues of $862 Million and International Profit Sharing of $283 Million ; Global Venclexta Net Revenues Were $505 Million
  • Second-Quarter Global Net Revenues from the Neuroscience Portfolio Were $1.658 Billion , an Increase of 13.7 Percent on a Reported Basis, or 15.2 Percent on an Operational Basis; Global Botox Therapeutic Net Revenues Were $678 Million ; Vraylar Net Revenues Were $492 Million
  • Second-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.371 Billion , a Decrease of 4.4 Percent on a Reported Basis, or 2.1 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $695 Million ; Global Juvederm Net Revenues Were $344 Million , Unfavorably Impacted by COVID-19 Restrictions in China and Suspension of Aesthetics Operations in Russia
  • Confirms 2022 Adjusted Diluted EPS Guidance Range of $13.78 - $13.98 , which Includes an Unfavorable Impact of $0.23 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the Second Quarter 2022

ABBVie (NYSE:ABBV) announced financial results for the second quarter ended June 30, 2022 .

"We delivered another strong quarter with substantial progress for our new products and indications. Importantly, Skyrizi and Rinvoq continued their impressive ramps and are on pace to deliver approximately $7.5 billion in combined annual sales, underscoring their significant potential," said Richard A. Gonzalez , chairman and chief executive officer, AbbVie. "The momentum of our business, combined with advances across our pipeline continue to support AbbVie's promising long-term outlook."

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×