Global Briefs: Samsung Bioepis, Sanofi, Hikma & More

A roundup of news from Samsung Bioepis, Biogen, Sanofi, Hikma, European Medicines Agency, Verrica, Helsinn, Regeneron, GSK’s ViiV Healthcare, HK inno.N, and Ilias Biologics. Highlights below.

* Biogen, Samsung Bioepis Launch Biosimilar of Roche’s Lucentis in US
* FDA Halts Trial for Sanofi’s Rx-OTC Switch for Cialis
* Hikma CEO To Step Down
* EMA Issues Final Guideline on Antimicrobial Resistance
* Verrica Gets FDA Complete Response Letter for Mfg Issues
* Helsinn Launches R&D Hub in the US
* Regeneron Completes Acquisition of Checkmate Pharmaceuticals
* GKS’s ViiV To Expand Access to HIV Drug
* HK inno.N, Ilias Biologics in Exosomes Drug-Delivery Pact

Biogen, Samsung Bioepis Launch Biosimilar of Roche’s Lucentis in US
Biogen and Samsung Bioepis, a biosimilars joint venture between Samsung Biologics, a biologics CDMO, and Biogen, have launched in the US Byooviz (ranibizumab-nuna), a biosimilar referencing Roche’s Lucentis (ranibizumab), an eye-care drug.

Roche’s Lucentis had 2021 global revenues of $1.4 billion. The FDA approved Byooviz in September 2021 for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

Byooviz will be commercially available on July 1, 2022, through major distributors across the US.

Earlier this year (April 2022), Samsung Biologics, completed the acquisition of Biogen’s 50% stake in Samsung Bioepis for $2.3 billion. Biogen initially took a 15% stake in Samsung Bioepis when it was established as a joint venture in 2012. It later exercised an option in 2018 to purchase up to 50% less one share of Samsung Bioepis. Following the buyout of Biogen in the joint venture, Samsung Bioepis and Biogen will continue with exclusive agreements in their biosimilars portfolio.

Source: Samsung Bioepis and Biogen

FDA Halts Trial for Sanofi’s Rx-OTC Switch for Cialis
The US Food and Drug Administration (FDA) has informed Sanofi that its planned actual use trial (AUT) to support the Rx-to-OTC switch for Cialis (tadalafil), a drug to treat erectile dysfunction and benign prostatic hyperplasia, has been placed on clinical hold due to matters surrounding the protocol design of the trial. Sanofi’s AUT has not yet recruited any patients. Sanofi said it continues to work with the FDA to move the Cialis program forward and will engage the FDA in upcoming meetings to determine the next steps.

Source: Sanofi

Hikma CEO To Step Down
Hikma Pharmaceuticals, a pharmaceutical company of branded and non-branded generic medicines. has announced that its CEO, Siggi Olafsson, has resigned as CEO and from Hikma’s Board of Directors.

Said Darwazah, Hikma’s Executive Chairman and former CEO, will assume all CEO responsibilities. Siggi will remain available to the company until he departs on June 24, 2022. Hikma’s Board has initiated an externally facilitated process to identify a new CEO.

Source: Hikma Pharmaceuticals

EMA Issues Final Guideline on Antimicrobial Resistance
As part of its efforts to support a global approach to the development of new antimicrobial medicines, the European Medicines Agency (EMA) has published a final revised guideline on the evaluation of human medicines for the treatment of bacterial infections.

As antimicrobial resistance (AMR) is a global threat, regulators in the EU, the US, and Japan have agreed to align their respective data requirements so that medicine developers can design clinical trials that meet the evidence needs of multiple regulatory agencies. The EMA’s revised document reflects the outcome of these discussions, and also includes: (1) clarifications on recommended clinical development programs for antimicrobials intended to address an unmet need; (2) guidance on clinical trials to support treatment of uncomplicated urinary tract infections and uncomplicated gonorrhea; and (3) updated guidance on displaying microbiological and clinical efficacy data in the summary of product characteristics.

The revised guideline is published with an addendum aiming to steer clinical development programs required to support the authorization of medicines for treatment of bacterial infections in children.

Source: European Medicines Agency

Verrica Gets FDA Complete Response Letter for Mfg Issues
The US Food and Drug Administration has issued Verrica Pharmaceuticals, a West Chester, Pennsylvania-based dermatology therapeutics company, a Complete Response Letter (CRL) in the company’s new drug application for VP-102, a non-sterile topical dermatology product for treating molluscum contagiosum, a viral skin disease.

According to the CRL, the FDA identified deficiencies at a general reinspection of Sterling Pharmaceuticals Services, the CMO that manufactures Verrica’s bulk solution drug product. The deficiencies identified are not specifically related to the manufacturing of VP-102.

Sterling had advised Verrica earlier this month (May 2022) that it received notice that it is on Official Action Indicated (OAI) status with the FDA. An OAI classification means objectionable conditions were found and regulatory action should be recommended. Sterling’s OAI classification resulted from a week-long reinspection of the CMO conducted by the FDA in February 2022. The reinspection was conducted after Sterling was originally classified by the FDA as Voluntary Action Indicated (VAI) in November 2021. A VAI classification means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

Verrica says it currently working with Sterling and its regulatory and quality consultants to help Sterling present multiple options to the FDA to allow Sterling to satisfy the majority of the deficiencies resulting in its OAI classification and which are the basis for the CRL. Concurrently, Verrica is engaging an additional CMO to serve as an alternative supplier of VP-102’s bulk solution.

Source: Verrica

Helsinn Launches R&D Hub in the US
Helsinn, a Lugano, Switzerland-based pharmaceutical company focused on cancer-care products, has established a new dedicated R&D hub at its US subsidiary, Helsinn Therapeutics (US).

The new hub is the next step in Helsinn’s strategy of creating a differentiated pipeline of oncology assets and transforming Helsinn from a cancer supportive care company to a fully integrated targeted therapy company. Over the next five years (as reported on May 25, 2022), Helsinn intends to invest approximately 35% of its revenues from its commercial supportive care and cancer therapeutic products into targeted therapeutics R&D.

Source: Helsinn

Regeneron Completes Acquisition of Checkmate Pharmaceuticals
Regeneron Pharmaceuticals, a Tarrytown, New York-based bio/pharmaceutical company, has completed its $250-million acquisition of Checkmate Pharmaceuticals, a Cambridge Massachusetts-based clinical-stage bio/pharmaceutical company. Regeneron had announced the acquisition in April (April 2022).

Checkmate’s lead investigational candidate is vidutolimod, which is currently being studied in combination with other agents for treating melanoma, non-melanoma skin cancers, and head and neck cancer.

Source: Regeneron Pharmaceuticals

GKS’s ViiV To Expand Access to HIV Drug
ViiV Healthcare, a specialist HIV company majority owned by GlaxoSmithKline (GSK), is entering into negotiations on voluntary licensing terms with the Medicines Patent Pool (MPP), a United Nations-backed public health organization, to help enable at scale access to a long-acting version of Viiv’s cabotegravir, for HIV pre-exposure prophylaxis (PrEP). 

Cabotegravir LA for PrEP is a long-acting injectable, which has recently gained its first regulatory approval for use in the US. It is not currently approved for use anywhere outside of the US. ViiV Healthcare has submitted marketing applications in a number of countries, including in sub-Saharan Africa.

This builds on a partnership between ViiV Healthcare and MPP in facilitating the manufacture and sale of low-cost versions of ViiV Healthcare medicines in countries most affected by HIV. Voluntary licensing has enabled access in low- and middle-income countries to another of ViiV’s medicines, dolutegravir.

Source: ViiV Healthcare

HK inno.N, Ilias Biologics in Exosomes Drug-Delivery Pact
HK inno.N, a company that develops and manufactures pharmaceuticals products, and Ilias Biologics, a Daejeon, South Korea-based biotechnology company, have signed a memorandum of understanding to discover and develop new drug candidates using exosomes.

Source: Ilias Biologics