Dr Reddy’s Partners with Gilead for Lenacapavir Licensing

Key Takeaways from Dr Reddy’s Partnership with Gilead Sciences:

• Dr Reddy’s Laboratories has entered a royalty-free, non-exclusive licensing agreement with Gilead Sciences for Lenacapavir in India and 120 other countries.
• Lenacapavir is FDA-approved for treating multidrug-resistant HIV-1 in heavily treatment-experienced adults and is under investigation for HIV prevention (PrEP).
• Gilead launched Lenacapavir, branded as Sunlenca®, in the U.S. and Europe in 2022.
• Dr Reddy’s will manage technology transfer, conduct studies, and handle product registration and launch in the agreed markets, and may also manufacture Lenacapavir for HIV prevention if approved.

Lenacapavir is an FDA-approved drug for treating HIV-1 infection in heavily treatment-experienced adults who have multidrug-resistant HIV. It is also being studied for HIV prevention (PrEP), but it has not yet been globally approved for this use.

Gilead launched Lenacapavir, branded as Sunlenca®, in the U.S. and Europe in 2022. As part of the agreement, Dr Reddy’s will handle the technology transfer at its manufacturing site, conduct necessary studies, and manage product registration and launch in the specified markets. 

The agreement also allows Dr Reddy’s to manufacture Lenacapavir for HIV prevention if it receives approval.

About Dr Reddy’s Laboratories Limited:

Dr Reddy’s Laboratories Limited is a global pharmaceutical company based in Hyderabad, India, founded in 1984. The company focuses on providing affordable and innovative medicines, guided by the mission of "Good Health Can’t Wait." They offer a range of products, including active pharmaceutical ingredients (APIs), generics, branded generics, biosimilars, and over-the-counter medications. Their main therapeutic areas include gastrointestinal issues, cardiovascular health, diabetes, oncology, pain management, and dermatology.

Dr Reddy’s operates in major markets like the USA, India, Russia and CIS countries, China, Brazil, and Europe. Known for its strong scientific background and commitment to innovation, the company has set high standards for sustainability and corporate governance, having released its first Sustainability Report in 2004. Their current environmental, social, and governance (ESG) goals focus on improving environmental practices, ensuring patient access and affordability, promoting diversity, and enhancing governance.

About Gilead Sciences:

For 35 years, Gilead has focused on discovering, developing, and delivering innovative therapies for areas with significant unmet medical needs. The company has played a key role in transforming HIV from a fatal disease into one that can be effectively managed and has cured millions of people with hepatitis C globally. Gilead’s extensive research on emerging viruses enabled them to provide the first approved treatment for COVID-19. Additionally, in partnership with Kite, a Gilead Company specialising in cell therapy, they are making strides in treating various types of cancer. Recognised for its dedication to innovation and access, Gilead aims to achieve its goal, set in 2019, of delivering over 10 transformative therapies by 2030.

About Lenacapavir:

Lenacapavir is a drug approved in several countries for treating adults with multidrug-resistant HIV, usually in combination with other antiviral medications. Its use for HIV prevention is still being studied, and its safety and effectiveness for that purpose have not yet been proven.

Lenacapavir works differently from many other antiviral drugs, targeting multiple stages of the HIV lifecycle rather than just one. This means it has no known resistance to other drug classes. It is being tested as a long-acting treatment option in various clinical studies aimed at HIV prevention and treatment. The goal is to develop long-acting oral and injectable forms of the drug with different dosing schedules to meet the needs of people living with HIV.

Key Takeaways from Alembic Pharma’s Nod for Lamotrigine Extended-Release Tablets:

• Alembic Pharmaceuticals has received final approval from the USFDA for its Lamotrigine Extended-Release Tablets in dosages of 200 mg, 250 mg, and 300 mg.
• The approved product is therapeutically equivalent to GlaxoSmithKline's Lamictal XR Extended-Release Tablets.
• The Lamotrigine tablets are indicated for additional therapy for primary generalised tonic-clonic seizures and partial-onset seizures in patients aged 13 and older, and for conversion to monotherapy for those already on a single antiepileptic drug.
• The estimated market size for these tablets is around USD 163 million for the twelve months ending June 2024, and Alembic now holds a total of 216 ANDA approvals from the USFDA.

This approval is for the company's Abbreviated New Drug Application (ANDA), which is therapeutically equivalent to GlaxoSmithKline's Lamictal XR Extended-Release Tablets.

The Lamotrigine tablets are indicated for use as an additional therapy for primary generalised tonic-clonic seizures and partial-onset seizures in patients aged 13 and older. They are also approved for conversion to monotherapy in patients aged 13 and older who are already receiving a single antiepileptic drug.

The estimated market size for Lamotrigine Extended-Release Tablets is approximately USD 163 million for the twelve months ending June 2024, according to IQVIA. With this approval, Alembic now has a total of 216 ANDA approvals from the USFDA, including 188 final approvals and 28 tentative approvals.

About Alembic Pharmaceuticals Limited:

Alembic Pharmaceuticals Limited is a pharmaceutical company focused on research and development, and it has been a leader in healthcare since 1907. Based in India, Alembic is publicly listed and produces generic medicines for markets around the world. Its modern research and manufacturing facilities are approved by regulatory bodies in many developed countries, including the USFDA. Alembic is a key player in the branded generics sector in India, with its products recognized by both doctors and patients, supported by a marketing team of over 5,000 people.

Key Takeaways from Carborundum Universal Incorporation:

• Carborundum Universal Limited incorporated a wholly owned subsidiary, CUMI USA Inc., in Delaware, USA, on October 2, 2024.
• The new subsidiary will serve as a Special Purpose Vehicle (SPV) for the acquisition of membership interest in Silicon Carbide Products Inc.
• CUMI USA Inc. has a paid-up capital of USD 7 million and an authorised capital of USD 10 million, but it has not yet started operations, so no turnover is reported.
• The acquisition will involve cash consideration, with an initial subscription of USD 7 million for 70,000 shares, and the new entity will become a related party to Carborundum Universal Limited.

CUMI USA Inc. has a paid-up capital of USD 7 million and an authorised capital of USD 10 million. As a newly incorporated entity, it has not yet commenced operations, so its turnover is not applicable at this stage.

The new subsidiary will serve as a Special Purpose Vehicle (SPV) for the acquisition, and the membership interests in Silicon Carbide Products Inc. will be held by CUMI USA Inc. 

The acquisition will involve cash consideration, with an initial subscription to the share capital amounting to USD 7 million, divided into 70,000 shares of USD 100 each. 

About Carborundum Universal Limited:

Carborundum Universal Limited (CUMI), established in 1954 as a tripartite joint venture, is a leading provider of materials science engineering solutions. As part of the 120-year-old Murugappa Group, CUMI is listed on both the NSE and BSE. The company operates as a Mines to Market company with integrated processes that include mining, power generation, fusion, manufacturing, marketing, and distribution. With a workforce of over 5,500 employees worldwide, CUMI focuses on collaboration and innovation to develop high-quality material solutions and services in areas such as abrasives, electro minerals, ceramics, refractories, and energy storage materials. Their products serve various industries, including engineering, fabrication, automotive, infrastructure, steel, glass, power generation and distribution, mining, and aerospace. CUMI has a broad global presence, exporting products to more than 50 countries across six continents.

Key Takeaways from Zydus Approval for Enzalutamide Tablets:

• Zydus Lifesciences Limited has received tentative approval from the USFDA to manufacture Enzalutamide Tablets in 40 mg and 80 mg.
• Enzalutamide is used to treat castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer.
• The tablets will be produced at Zydus's facility in the Special Economic Zone (SEZ) in Ahmedabad.
• Enzalutamide tablets had annual sales of approximately USD 1.42 billion in the United States as of July 2024, and Zydus now has 400 total approvals.

The Enzalutamide tablets will be produced at Zydus's manufacturing facility in the Special Economic Zone (SEZ) in Ahmedabad. In the United States, Enzalutamide tablets generated annual sales of approximately USD 1.42 billion as of July 2024.

With this latest approval, Zydus now has a total of 400 approvals and has filed over 465 Abbreviated New Drug Applications (ANDAs) since starting the filing process in the fiscal year 2003-04.

About Zydus Lifesciences Limited:

Zydus Lifesciences Limited is a global healthcare company focused on helping people live healthier and more fulfilling lives. They discover, develop, manufacture, and market a variety of healthcare therapies, with a strong emphasis on cancer treatments that include cytotoxic, supportive, and targeted drugs. The company employs over 27,000 people worldwide, including 1,400 scientists in research and development. Their mission is to create innovative healthcare solutions that make a difference in people's lives and to achieve transformative discoveries.