A provision of the “Inflation Reduction Act” (IRA) could threaten investments in “small molecule” drug development, said a visiting professor at Rutgers University.
There are currently up to 7 Union County biopharma companies involved in that type of drug development, according to Biopharmguy.com, including 3 in Berkeley Heights, 3 in Rahway, and 1 in Westfield.
“Merck, Johnson & Johnson, Pfizer, BMS, all of those are small molecule companies that are based in New Jersey that could be impacted,” Shah told Somerset Times. “Biologics are great for dealing with complex diseases, but small molecules will have a greater benefit to the US population in many years to come, because it’s easy to produce many generics that will be available.”
In addition to serving as a visiting professor at Rutgers University, Shah is president of Market Access Solutions, a Raritan, NJ-based consulting firm that works with pharmaceutical and biotech companies.
The IRA, signed into law by President Joe Biden (D) in 2022, contains a drug provision in which the brand-name drugs for which Medicare “negotiates” prices are split into two categories: small-molecule drugs and biologics.
The IRA makes small-molecule drugs eligible for “negotiation” nine years after their approval, compared to a 13-year exemption period for biologics.
Shah co-authored a March 29 op-ed in NorthJersey.com that said the IRA “penalizes research” on small molecule drugs and would have “painful consequences for patients.”
He said a pending U.S. House bill, the “Ensuring Pathways for Innovative Cures (EPIC) Act” would equalize the exemption period for both biologic and small-molecule drugs. By granting both types of drugs a 13-year exemption, he said the bill would incentive innovation in small-molecule research.
“Make it both same and give the same incentives to both small-molecule factor as well as biologic small molecules,” said Shah.
Otherwise, he said, the IRA provision amounts to “price controls” that will curtail investment in small molecule drugs.
An October 2023 paper, authored by University of Chicago economists, said that the IRA small molecule provision will result in “188 fewer small molecule treatments, including 79 fewer new small molecule drugs and 109 fewer post-approval indications for these drugs.”
How many New Jersey biopharma companies are involved in “small molecule” drug development?
Source: Biopharmguy.com
| Company |
City/Town |
Type of Drug Development |
| Daiichi Sankyo |
NJ – Basking Ridge |
Small Molecules, Biologics |
| Regeneron |
NJ – Basking Ridge |
Small Molecules, Biologics |
| Jubilant Therapeutics |
NJ – Bedminster |
Small Molecules |
| Chugai Pharma |
NJ – Berkeley Heights |
Small Molecules |
| CorMedix |
NJ – Berkeley Heights |
Small Molecules |
| Cyclacel Pharmaceuticals |
NJ – Berkeley Heights |
Small Molecules, Biologics |
| Vyne Therapeutics |
NJ – Bridgewater |
Small Molecule |
| Asana BioSciences |
NJ – Bridgewater |
Small Molecule, Biologics |
| Amarin |
NJ – Bridgewater |
Small Molecules |
| Bausch Health |
NJ – Bridgewater |
Small Molecules |
| Lexicon Pharmaceuticals |
NJ – Bridgewater |
Small Molecules, Biologics |
| Sanofi |
NJ – Bridgewater |
Small Molecules, Biologics |
| Salix Pharmaceuticals |
NJ – Bridgewater |
Specialty Small Molecules, Gastroenterological |
| Klus Pharma |
NJ – Cranbury |
Generics, Biologics Development, Small Molecules |
| IVIEW Therapeutics |
NJ – Cranbury |
Small molecule for ophthalmology |
| Palatin Technologies |
NJ – Cranbury |
Small Molecules |
| Cornerstone Pharmaceuticals |
NJ – Cranbury |
Small Molecules, Delivery |
| Novartis |
NJ – East Hanover |
Small Molecules, Vaccines, Biologics |
| Lavipharm |
NJ – East Windsor |
Small molecules |
| Cellectar Biosciences |
NJ – Florham Park |
Small Molecules |
| Shionogi |
NJ – Florham Park |
Small Molecules |
| Mezzion Pharmaceuticals |
NJ – Fort Lee |
Small Molecules |
| Nuvectis Pharma |
NJ – Fort Lee |
Small Molecules |
| Linnaeus Therapeutics |
NJ – Haddonfield |
Small Molecules for Cancer |
| Celldex Therapeutics |
NJ – Hampton |
Small Molecules, Biologics, Vaccines |
| Helsinn |
NJ – Iselin |
Small Molecules |
| Mitsubishi Tanabe Pharma |
NJ – Jersey City |
Small Molecules |
| Scynexis |
NJ – Jersey City |
Small Molecules |
| Almatica Pharma |
NJ – Morristown |
Small Molecules |
| Intercept Pharmaceuticals |
NJ – Morristown |
Small Molecules |
| AIM ImmunoTech |
NJ – New Brunswick |
Small Molecules, Biologics |
| Bristol Myers Squibb |
NJ – New Brunswick |
Small Molecules, Biologics |
| Eisai |
NJ – Nutley |
Small Molecules |
| NS Pharma |
NJ – Paramus |
Small Molecule |
| SK Life Science |
NJ – Paramus |
Small Molecules for CNS |
| Teva |
NJ – Parisppany |
Small Molecules, Biologics |
| Melinta Therapeutics |
NJ – Parsippany |
Small Molecule Discovery |
| Ferring Pharmaceuticals |
NJ – Parsippany |
Small Molecules, Biologics |
| SPES Pharmaceuticals |
NJ – Plainsboro |
505 b(2) Small Molecules |
| Soligenix |
NJ – Princeton |
Lipoprotein Delivery, Small Molecules |
| Taiho Oncology |
NJ – Princeton |
Oncology small molecules |
| Medicure |
NJ – Princeton |
Small Molecule |
| Beta Pharma |
NJ – Princeton |
Small Molecules |
| KBP BioSciences |
NJ – Princeton |
Small Molecules |
| Oblato |
NJ – Princeton |
Small Molecules |
| Zywie |
NJ – Princeton |
Small Molecules for Protein Misfolding diseases |
| Juvenescence |
NJ – Princeton |
Small Molecules, Biologics |
| Merck |
NJ – Rahway |
Small Molecules, Biologics |
| Merck |
NJ – Rahway |
Small Molecules, Vaccines, Biologics |
| Merck |
NJ – Rahway |
Small Molecules, Vaccines, Biologics |
| Janssen Pharmaceuticals |
NJ – Raritan |
Small Molecules, Biologics |
| BeiGene |
NJ – Ridgefield Park |
Small Molecules, Monoclonal Antibodies |
| ReVision Therapeutics |
NJ – Ridgewood |
Small Molecules |
| PTC Therapeutics |
NJ – South Plainfield |
Small Molecules |
| Janssen Pharmaceuticals |
NJ – Titusville |
Small Molecules, Biologics |
| GSK |
NJ – Warren |
Small Molecules, Vaccines, Biologics |
| Medimetriks Pharmaceuticals |
NJ – West Fairfield |
Specialty Pharma – Derm & Podiatry |
| Issar Pharmaceuticals |
NJ – West Orange |
Small Molecules |
| Acquist Therapeutics |
NJ – Westfield |
Small molecule for chronic inflammatory disorders |
