Industry Briefs December 2022

Amazon Goes DTC

In its latest venture into the healthcare arena, Amazon is reaching out directly to the consumer via its soon-to-be-launched Amazon Clinic, a virtual health service for patients to see licensed clinicians about common medical issues. From hair loss to allergies and acne, Amazon Clinic allows patients to message clinicians for a diagnosis, treatment, and medication prescription. The message-based telehealth services are provided in partnership with providers such as SteadyMD and are designed to connect seamlessly with Amazon Pharmacy, which fills and delivers medications to patients’ homes.

The interface will tell patients care pricing upfront and provide an estimated wait time whenever logging into the Amazon Clinic. The services are cash pay only at this point. Aaron Martin, Amazon’s Vice President of Healthcare explained during the HLTH conference 2022 that: “It’s going to be partnership-focused and enable our audience, the folks who are using, to find, discover, and get access to some really awesome, innovative new technologies that might help them.”

The launch of Amazon Clinic is happening as Amazon Care, a hybrid suite of urgent care and primary care services piloted with Amazon employees and their families in the Seattle region in 2019, shuts down. Offering a so-called “healthcare store” experience, Amazon Clinic will be accessible by customers in 32 states, 24/7, via or the mobile app.

Nworah Ayogu, MD, Amazon Clinic Chief Medical Officer and General Manager, wrote a blog post about Amazon Clinic, stating, “Amazon Pharmacy and One Medical (once the deal closes) are two key ways we’re working to make care more convenient and accessible. But we also know that sometimes you just need a quick interaction with a clinician for a common health concern that can be easily addressed virtually. We believe that improving both the occasional and ongoing engagement experience is necessary to make care dramatically better.”

As Dr. Ayogu referred to, Amazon is also in the midst of a $3.9 billion deal to acquire One Medical, a consumer-focused primary care physician platform with 815,000 members and 188 medical clinics across the country, which would expand Amazon Clinic’s reach considerably.

Pfizer’s Giant Ireland Investment

Pfizer has finally announced its major investment plans for upgraded manufacturing facilities in Dublin, Ireland. The company is pouring 1.2 billion euros into its new facility where it is planning to hire 400 and 500 new personal by 2027. As the pharma giant’s production and laboratory capabilities for biological drug substance manufacturing are set to increase, it will bring their Ireland employee base to roughly 5,500 people, their largest investment in the country yet. Just last year, Pfizer spent 40 million euros to bring the same manufacturing facility into its global COVID-19 vaccine manufacturing network. AbbVie and AstraZeneca are also upping their investments and manufacturing focus in Ireland with deals on new sites closed this past year.

The Cannabis Market Is Set to Explode

As medical cannabis uses progress in the U.S., the market is positioned to grow massively, projected to hit $147 billion by 2027. The Insight Partners market research shows that the industry could grow at a CAGR of 29.1%, increasing from a market size value of $14.3 billion in 2019. While projections are global, the U.S. is the major contributor to this rise with 30 states having legalized the use of cannabis, medicinally or for general adult use. The U.S. boasts 8,000 active licenses issued to cannabis businesses, leading the pack in countries with the largest markets.

Despite negative impacts from the COVID-19 pandemic that included supply chain shortages, lockdown restrictions, and other loss of services, many cannabis companies have recovered completely with the help of digital services to their customers. As of yet, the FDA has only approved medical cannabis in the form of CBD products used for treating epilepsy seizures and nausea caused by chemotherapy, though it is prepared to review studies for several other indications currently in trials.

Making All Biosimilars Interchangeable

A new act being proposed by Senator Mike Lee may automatically allow all biosimilars to be switched at the pharmacy counter for its reference drug without a study.

When Coherus BioSciences received FDA approval for Cimerli, a biosimilar to Roche’s eye disease medicine Lucentis, it was also granted drug interchangeability without requiring a switching study. This means the biosimilar can be switched at the pharmacy counter for its reference drug, just as pharmacies do with generic vs. brand name medicines, without a study that proves there would be any loss of safety, potency, or purity.

This play sped up access to the affordable drug, prompting Senator Mike Lee (R-Utah) to propose complete elimination of switching studies for biosimilars going forward. The Biosimilar Elimination Red Tape Act is intended to speed access to biosimilars by making them all interchangeable automatically. So far, the FDA has only granted the interchangeability status to four of the 39 biosimilars it has approved. Some say this approval is redundant and confusing as it simply allows pharmacists to switch to the copycat product without the consultation of a doctor, yet makes it more time consuming and expensive for biosimilars to make it to market.

Boston Scientific Acquires Gastro Device Company

The leading biotech company has closed a cash offer of about $615 million for Apollo Endosurgery, the gastrointestinal device company known for its marketing of the minimally invasive Lap-Band device for weight loss, before it was taken over by ReShape Lifesciences in 2018. Apollo is developing a number of endoscopic suturing systems, including the Orbera weight loss balloon implant.

“Endoluminal surgery is an emerging field and a core focus for our endoscopy business,” Mike Jones, Senior Vice President and President of Endoscopy at Boston Scientific, stated in a press release. “This acquisition also enables us to enter a new adjacency—the endobariatric market—and deliver strong, continued growth across our business.”

Sanofi Tackles Sleeping Sickness

Sanofi in partnership with the Drugs for Neglected Diseases initiative is showing promising results on a new treatment for sleeping sickness.

Sleeping sickness, a largely understudied parasitic disease transferred by fly bite and endemic to Africa, is being targeted by Sanofi and the Drugs for Neglected Diseases initiative (DNDi). The company announced that Phase II/III clinical trials show 95% effectiveness in their drug acoziborole for treating sleeping sickness. Left untreated, the disease is fatal, initially causing fever and muscle aches until the disease crosses the brain barrier, bringing about confusion, sensory disturbances, poor coordination, and disturbance of the sleep cycle. The World Health Organization aims to eliminate the disease by 2030. Without any current treatment, that goal has become much more attainable with the projected efficacy of Sanofi’s new drug.

A principal investigator in the acoziborole clinic trials, Dr. Victor Kande, states “Sleeping sickness is a nightmare disease that affects patients in some of the most remote settings in West and Central Africa, where distance from hospital can be measured in days. We are now on the cusp of a potential treatment that can be given in one day, in a single dose of three pills—this would be a revolution for doctors and communities.” With a simple and sustainable response to the disease, outbreaks could be more easily controlled even in remote areas without access to sophisticated healthcare, bringing the world closer to eliminating the disease permanently.


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