It’s day three of the 40th annual J.P. Morgan Healthcare Conference. We’ve already heard about Amgen’s biosimilar ambitions and Gilead Sciences’ long-term HIV strategy, but there’s still plenty of action to come. Be sure to check in throughout the day to get the skinny on all the biggest happenings from the virtual conference.
For instance, today we're hearing about Eli Lilly's plans for its forthcoming diabetes med tirzepatide, Ipsen's dealmaking plans and Bausch Health's progress toward its three-way split.
To look back at Fierce Pharma’s coverage from Day 2, click here. For Day 1, click here. And check out Fierce Biotech’s Day 2 coverage here.
UPDATED: Wednesday, Jan. 12 at 6:55 p.m. ET
The three things that matter in contract manufacturing? Capacity, capacity and capacity. That was a major theme during Samsung Biologics’ presentation, and—recalling that location is important, too—the CDMO touched on expansion opportunities beyond its home base in Korea.
Last year the company achieved all four goals it laid out at 2021’s JPM conference, CEO John Rim said Wednesday. The company hastened the build out of Plant 4, its “Super Plant” in Incheon, South Korea, by six months. Samsung also maximized the use of its factories, branched out into mRNA and cemented its spot near the head of the biosimilar pack, Rim said.
Samsung’s Super Plant will boast a whopping 620,000 liters of capacity when it becomes fully operational, which is expected in the second quarter of next year. An initial 60,000 liters will be available in the fourth quarter of 2022, Rim said. Separately, the company is homing in on a deal for another, larger campus in Korea.
The company has already grown from South Korea to San Francisco, and is “continuing to look at the United States for expansion at this time,” Rim said. Samsung is also eyeing Europe for expansion opportunities.
UPDATED: Wednesday, Jan. 12 at 5:48 p.m. ET
Three years ago, when Perrigo began its transformation into a consumer self-care company, its CEO Murray Kessler often found himself having to spell out what that meant.
“Folks were like, ‘Explain to me what that is. What is self-care?’" Kessler said on Wednesday. “Here we are a few years later and not only are we a top player in consumer self-care, but there’s a new industry, a dedicated and focused industry that is formed.”
With Johnson & Johnson spinning out a new publicly traded company to handle its consumer health business, mirroring similar moves by Merck, Sanofi, GlaxoSmithKline and Pfizer, there has become more awareness of this sector in a short time.
There’s also an understanding that these businesses can operate more efficiently by themselves. In this new environment, Perrigo is a “top seven player,” on a net sales basis, Kessler points out.
“This is exciting to us because with this focus of these companies will come many opportunities in new products,” Kessler said.
UPDATED: Wednesday, Jan. 12 at 5:28 p.m. ET
After a false start in Europe, bluebird bio is eager to push its trio of gene therapies out of the nest in the U.S., CEO Andrew Obenshain said. First up is the beta-thalassemia therapy beti-cel, which the FDA is expected to rule on in May. Next comes eli-cel in cerebral adrenoleukodystrophy, with a regulatory verdict slated for June. Finally, by the first quarter of next year, bluebird plans to submit lovo-cel for sickle cell disease, where the company foresees blockbuster potential.
All told, there are upward of 22,000 U.S. patients that bluebird could reach with its gene therapy trio. The company will start by targeting roughly 1,500 people with beta-thalassemia to lay the groundwork for subsequent product debuts. To prepare for that launch, bluebird is building treatment centers, dispensing gene therapy education, rolling out a patient support program and talking coverage with payers, Obenshain said.
The plan, then, is to use that beta thalassemia bedrock in pursuit of some 20,000 severe patients with sickle cell disease in 2023. While beta thalassemia and sickle cell are two “very different diseases,” there’s significant prescriber overlap, and 100% of bluebird’s beta thalassemia treatment centers are expected to become sickle cell treatment centers, too, Obenshain said.
UPDATED: Wednesday, Jan. 12 at 3:01 p.m. ET
Legend Biotech is prepping its Johnson & Johnson-partnered, “paradigm shifting” CAR-T multiple myeloma treatment cilta-cel for launch with a global manufacturing operation, which CEO Ying Huang, Ph.D., hopes will avoid the supply challenges suffered by companies that have come before them in cell therapy.
Cilta-cel is ready to go as soon as the FDA gives its OK, which is expected in February. Thousands of staff and a global manufacturing operation built out with partner J&J are standing by to roll out the blood cancer CAR-T therapy, Huang said at the annual J.P. Morgan Healthcare Conference. The company is is determined not to have the same supply challenges as Bristol Myers, Novartis, Gilead Sciences and others in the field. Story
UPDATED: Wednesday, Jan. 12 at 12:45 p.m. ET
Bausch Health has done the legwork necessary to split into three companies, CEO Joe Papa said on Wednesday. As previously announced, Bausch will separate from its medical aesthetics sector as Solta and its eye health business as Bausch & Lomb. When the market conditions dictate, Papa said, Bausch will file with the SEC to take those companies public.
“We can do them in either order,” said Papa, who declined to say which would go first. “We want to make sure we do what’s right for each of those businesses respectively.”
A major goal of the initiative is to reduce the debt the company incurred during its troubled era when it was known as Valeant Pharmaceuticals. Since Papa took over as CEO in 2016, the company has reduced its debt by $10 billion, but there’s still $20 billion to go.
Proceeds from the IPOs will help draw down the debt, Papa said. Nothing is written in stone however. The company has done $4 billion worth of divestment under Papa and could do the more if the right deal comes along.
“We’re looking at all the things public companies have to do to be successful,” Papa said. “We’re always open to options that will create shareholder value, which may include divestitures that add an appropriate premium price.”
UPDATED: Wednesday, Jan. 12 at 9 a.m. ET
Ipsen is targeting €3 billion in dealmaking firepower by 2024, Craig Marks, the company’s vice president of investor relations said during JPM. The number could grow further as the French pharma is in the process of a strategic review of its consumer health unit, which could reportedly be valued at $500 million in the case of a potential sale.
Buying or in-licensing external innovations is a key strategy of Ipsen. The company is Exelixis’ ex-U.S. partner for Cabometyx, which expects phase 3 readout for a combination with Roche’s PD-L1 inhibitor Tecentriq in second-line non-small cell lung cancer in the second half of 2022.
Last year, Ipsen completed seven transactions across oncology, rare disease and neuroscience, including paying €120 million upfront for global rights to Genfit’s phase 3 asset elafibranor for primary biliary cholangitis.
Moving forward, Ipsen will continue to look for deals across the development stages, including for programs with unblinded phase 3 data or even marketed products, in those three therapeutic areas, Marks said. The company is also looking to beef up its U.S. presence through dealmaking.
UPDATED: Wednesday, Jan. 12 at 8:15 a.m. ET
Could Eli Lilly divide upcoming diabetes hopeful tirzepatide into multiple brands? It’s possible, Lilly CEO David Ricks hinted at the 2022 J.P. Morgan Healthcare Conference. The move wouldn’t be unprecedented: Lilly’s Danish rival Novo Nordisk already splits its injectable GLP-1 med semaglutide into two separate brands: Ozempic for diabetes and Wegovy for obesity. “We’re having those discussions,” Ricks said when asked about a two-brand strategy, adding that he sees pros and cons "on all sides."
The strategy made sense in the past because there was “a pretty different market for those obesity treatments than diabetes,” Ricks said. Previously, payers have been more willing to pay for diabetes drugs at a price point they wouldn’t approach for obesity. Ricks, for his part, sees payers becoming “much more interested in treating obesity,” which in turn could help lower the risks of cardiovascular disease, diabetes, joint problems and a plethora of other complications. Story