• Pages
  • Editions
01 Cover
02 Welcome Letter / Sections
03 Section 1: Introduction
04 Introduction to USA Life Sciences Industry
05 Janssen Interview
06 Etihad Cargo Interview
07 UPS Healthcare Interview
08 The Investment Climate
09 MPM | BioImpact Capital Interview
10 Industry Insights: Promising Forecasts for Consolidation and M&As
11 The Regulatory Landscape
12 Porzio Life Sciences Interview
13 PBOA Interview
14 EY USA Interview
15 LaVoieHealthScience Interview
16 Section 2: Established and Emerging Hubs
17 Map of US-based life sciences companies interviewed
18 The East and the West
19 BioNJ Interview
20 MassBio Interview
21 Biocom California Interview
22 PABC Interview
23 Growing Life Sciences Hubs
24 JLL Interview
25 Industry Insights: From Ivory Towers to Incubators
26 Section 3: Drug Discovery and Development
27 Drug Discovery and Development
28 Sangamo Therapeutics Interview
29 PsychoGenics Interview
30 Aphios Corporation Interview
31 Industry Insights: Biotechs Fairing in 2023
32 Ymmunobio Interview
33 Section 4: Contract Manufacturing, Services and Chemicals
34 The Industry's Growing Reliance on CDMOs
35 Pfizer CentreOne Interview
36 CordenPharma International Interview
37 AMPAC Fine Chemicals Interview
38 Adare Pharma Solutions Interview
39 Aenova Group Interview
40 Dipharma Francis Interview
41 Kindeva Drug Delivery Interview
42 Prince Sterilization Services Interview
43 Interbiome Interview
44 Adopting a Proactive Stance
45 Lonza Interview
46 Aragen Life Sciences Interview
47 Industry Insights: Contractors, Manufacturers, and Lab Services
48 Nivagen Pharmaceuticals Interview
49 Chemicals and Service Providers
50 Evonik Health Care Interview
51 Section 5: New Technologies
52 Leveraging AI for Drug Discovery
53 Apprentice.io Interview
54 Technology for Patient Centricity
55 Illumina Interview
56 Section 6: Company Profiles
57 Porzio Life Sciences Company Profile
58 Adare Pharma Solutions Company Profile
59 SK pharmteco Company Profile
60 Article & Interview Directory
61 Credits

Jay Shukla President and CEO

NIVAGEN PHARMACEUTICALS

"Our partners benefit from our market intelligence and cost-splitting, and we attain the manufacturing capability and resources. We will continue to grow our partnership model now that we are expecting to double our revenue."

How has Nivagen Pharmaceuticals, Inc. (Nivagen) grown in 2022?

Nivagen is moving towards more sterile injectable products. We received first-to-file approvals by the FDA’s 180-day CGT (Competitive Generic Therapy) exclusivity in 2022, and we are expecting four more approvals before Q3 2023. We raised US$45 million in debt financing to build a 63,500-square-foot state-of-the-art sterile manufacturing R&D facility in California. We have started building our sterile manufacturing unit which will produce prefilled syringes, ready-to-use aseptic and terminally sterilized IV bags and cartridges, and we are hoping to complete the manufacturing construction by December 2023. Although we will continue manufacturing oral and topical products in partnership, our current long-term goal is to focus on the hospital market. There is still limited competition in the sterile injectable space compared to the oral space, and we can thus be extremely cost competitive in producing these products locally.

What will the cash flow from the US$45 million in financing unlock in 2023?

The construction of our new sterile manufacturing unit will allow us to onshore our production capabilities. By reshoring product manufacturing, we will be able to streamline our supply chain, reduce manufacturing costs, and ultimately time to market for new product launches. It will also allow us to provide CDMO services to pharma companies who want to hire us as a contract manufacturer for IV bags, prefilled syringes, or cartridge manufacturing. We will be able to provide complete research, analytical formulation development, regulatory support, and experience in filing applications to existing manufacturers and biotech companies. We are looking at more complex generics such as complex injectables, sustained-release microspheres, and nanotechnology. We are also expanding into 505(b)(2) programs and have submitted eight new applications with this regard where we are focusing on dual chamber IV bags, prefilled syringes, and repurposing existing molecules for new indications. Our new facility will give us significant flexibility in terms of what we can develop in-house and how we cater to the CDMO market.

Can you expand on Nivagen’s strategy of growth through partnerships and the advantages of the acquisition and licensing model?

Nivagen has established distribution channels, sales and marketing teams, and vendor agreements with customers and government agencies in all US states, and we also work as an extended sales and marketing team for foreign manufacturers who want to sell into the US market without having a physical presence in the country. We will only partner with companies that have robust supply, a quality system that will withstand FDA inspection, and that is financially strong enough to enter the US market. In terms of co-development, we will co-invest with partners in R&D programs and our partners will have the manufacturing rights while we keep the distribution rights. This is a win-win situation: our partners benefit from our market intelligence and cost-splitting, and we attain the manufacturing capability and resources. We will continue to grow our partnership model now that we are expecting to double our revenue.

How do you assess the current regulatory and generics landscape environment in the US?

The regulatory environment is becoming increasingly stringent, and more parameters are being included. Our biggest setback was the delay in the FDA inspecting our facility, but now that the FDA has started doing the inspections and approving the facility, we hope to see our approvals coming in more rapidly.

Generics have saved the healthcare system and consumers billions of dollars, and as more products are entering the market, prices are decreasing. At the same time, there is a consolidation in the wholesale business and not all the savings are passed to consumers as there is a middleman who picks a significant amount of the savings. This is however changing, and as more price transparency comes into play, more savings will be passed on to the consumer.

What are Nivagen’s key priorities for the next year?

We want to significantly grow our CDMO business, especially for manufacturing aseptic and terminally sterilized IV bags, prefilled syringes, cartridges, and dual chamber bags. We hope to be successful in the products we are awaiting approval for, commercializing our approved products, as well as significantly expanding into the hospital market. Having three revenue streams, we hope to double our revenues by the end of 2023.

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Article: Chemicals and Service Providers