On February 1, 2022 Biogen Inc. (Nasdaq: BIIB) reported that it exercised its option to participate in the development and commercialization of mosunetuzumab (Press release, Biogen, FEB 1, 2022, View Source [SID1234607566]). Biogen will pay a $30 million one-time option fee to Genentech, a member of the Roche Group, as part of the companies’ long-standing collaboration on antibodies targeting CD20.

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Mosunetuzumab is a CD20xCD3 T-cell engaging bispecific antibody in development for the treatment of people with B-cell non-Hodgkin’s lymphoma (NHL), including follicular lymphoma (FL)1 and diffuse large B-cell lymphoma (DLBCL). In June 2020, mosunetuzumab was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed/refractory (R/R) FL who have received at least two prior systemic therapies.

Genentech plans to complete a Biologics License Application (BLA) submission to the FDA in the near future for approval consideration from the GO29781 study investigating mosunetuzumab in patients with R/R FL. If approved, mosunetuzumab has the potential to be a first-in-class CD20xCD3 T-cell engaging bispecific antibody in NHL. Roche recently submitted the initial marketing authorization application for mosunetuzumab to the European Medicines Agency (EMA), with the hope to bring this drug as soon as possible to people with NHL. In addition, mosunetuzumab recently began a Phase 1b trial in patients with systemic lupus erythematosus2.

As a part of the option exercise, Biogen will pay a $30 million one-time option fee to Genentech and will pay for a portion of the mosunetuzumab development expenses incurred during 2021. Biogen will have joint decision-making rights related to development and commercialization of mosunetuzumab and Genentech will continue to lead the strategy and implementation of the program.

Biogen will share in the operating profits and losses of mosunetuzumab in United States in the low to mid 30% range and is eligible to receive low single-digit royalties on sales outside the United States.

On February 1, 2022 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will participate in the following virtual conferences and invited investors to participate by webcast (Press release, Exact Sciences, FEB 1, 2022, View Source [SID1234607565]).

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SVB Leerink Global Healthcare Conference
Fireside Chat on Friday, February 18, 2022 at 1:40 p.m. ET

Citi Healthcare Conference
Fireside Chat on Wednesday, February 23, 2022 at 2:45 p.m. ET
The webcasts can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

On February 1, 2022 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Guggenheim Oncology Conference on Wednesday, Feb. 9, 2022 (Press release, Eli Lilly, FEB 1, 2022, View Source [SID1234607564]). Jake Van Naarden, CEO of Loxo Oncology at Lilly and president, Lilly Oncology and David Hyman, M.D., chief medical officer, Lilly Oncology, will participate in a virtual fireside chat at 12 p.m., Eastern time .

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

On February 1, 2022 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported the commercial availability of its novel product PEMFEXY (pemetrexed for injection) (Press release, Eagle Pharmaceuticals, FEB 1, 2022, View Source [SID1234607563]). A branded alternative to ALIMTA, Eagle’s PEMFEXY is a ready-to-use liquid with a unique J-code approved to treat nonsquamous non-small cell lung cancer and mesothelioma.

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"We’ve spent the past several months building our inventory and are pleased that PEMFEXY will now be available to the many patients who need it. Together with our recent launch of vasopressin and now PEMFEXY, these products represent significant opportunities for Eagle," stated Scott Tarriff, President and Chief Executive Officer.

In February 2020, Eagle received final approval from the U.S. Food and Drug Administration of its New Drug Application for PEMFEXY, following the settlement agreement of patent litigation with Eli Lilly and Company (NYSE: LLY) in December 2019. The agreement provided for a release of all claims by the parties and allows for an initial entry of PEMFEXY into the market (equivalent to approximately a three-week supply of current ALIMTA utilization) on February 1, 2022 and a subsequent uncapped entry on April 1, 2022.

On October 1, 2020, PEMFEXY’s Healthcare Common Procedure Coding System code, or J-code, became effective.

About PEMFEXY

PEMFEXY is a pemetrexed injection ready-to-dilute formulation for locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin; locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy as a single agent; and malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery in combination with cisplatin.

On February 1, 2022 Dr. Reddy’s Laboratories Ltd. along with its subsidiaries together referred to as "Dr. Reddy’s") reported that it named Akhil Ravi as CEO for its wholly-owned subsidiary Aurigene Pharmaceutical Services Ltd. (APSL) effective February 1, 2022 (Press release, Dr Reddy’s, FEB 1, 2022, View Source [SID1234607562]).

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Since joining Dr. Reddy’s in 2018 from McKinsey & Company, Akhil Ravi has served as Head of Strategy for Services and Active Pharmaceutical Ingredients (APIs), and headed the Sales of APIs in Europe. In addition, he has also had a brief stint as Plant Head. Akhil holds a BTech degree in Chemical Engineering from IIT Bombay and an MBA from the Indian School of Business (ISB).

"Akhil is very well prepared for this role. He was instrumental in growing our API business through product development and an improved service experience for our B2B customers through digital platforms. His strong background in customer service, sales, strategy, and management make him an ideal leader for Aurigene, and we look forward to his accomplishments in this new role." said Deepak Sapra, CEO of API and Services at Dr. Reddy’s, and Member of the Board at Aurigene.

Akhil Ravi said: "Aurigene Pharmaceutical Services is a dynamic partner for global pharma companies. With its integrated services from clinical research up to commercial manufacturing for small and large molecules, it is able to significantly speed up the journey of an NCE/NBE (New Chemical and Biological Entities) to the patient. I am very thrilled to join Aurigene and work with the team to serve innovative global pharma and biotech companies."