Puerto Rico Pharma Supply Part 2: Who has back-up sites off the island?

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SEE END OF THIS REPORT FOR IMPORTANT DISCLOSURES

Richard Evans / Scott Hinds

203.901.1631 /.1632

revans@ / shinds@ssrllc.com

@SSRHealth

October 22, 2017

Puerto Rico Pharma Supply Part 2: Who has back-up sites off the island?

  • We believe that the following companies derive at least the following percentages of US prescription sales from products manufactured, in whole or in part, in Puerto Rico:
    • ABBV 72 percent
    • AMGN 67 percent
    • BMY 63 percent
    • JNJ 56 percent
    • PFE 26 percent
    • MRK 25 percent
    • LLY 22 percent
    • TKPYY 21 percent,
    • AZN 6 percent
  • We’ve cross referenced European Medicines Agency (EMA) and US Food and Drug Administration (FDA) databases to identify which products made in Puerto Rico also are (or at least have been) made in FDA-licensed facilities off the island. Products made on the island commonly have FDA-licensed non-Puerto Rico sources, with the following exceptions, for which we’ve been unable to identify non-Puerto Rico sources:
    • AMGN: Repatha and Aranesp, 7 percent of US pharmaceutical and 9 percent of global sales
    • BMY: Eliquis, 13 percent of US pharmaceutical and 11 percent of global sales
    • JNJ: Xarelto, Prezista, Invokana and Invega/Sustenna. 30 percent of US pharmaceutical and 11 percent of global sales
    • PFE: Lyrica, Eliquis, and Xeljanz, 26 percent of US pharmaceutical and 16 percent of global sales

In our first note[1] on Rx brand supply risks resulting from hurricane damage in Puerto Rico, we used FDA facilities registrations[2] to identify firms with manufacturing facilities on the island. We then searched FDA approvals documents and other media to determine which of these manufacturers’ products are made in their Puerto Rico facilities

For this follow-up we searched EMA[3] approval documents to further identify brand products manufactured in Puerto Rico, and to determine whether products made in Puerto Rico also are made, in whole or in part, in FDA approved facilities off the island

Exhibit 1 updates our summary of major products made in Puerto Rico. Products listed are those that account for ≥ 80 percent of firms’ disclosed US sales, and in some cases smaller products made in Puerto Rico also are listed. Changes are shaded, and links to source documents are provided as an appendix

Based on the findings in Exhibit 1, we believe that the following companies derive at least the following percentages of US prescription sales from products made, in whole or in part, on the island:

  • ABBV: at least 72 percent of US sales
  • AMGN: at least 67 percent of US sales
  • BMY: at least 63 percent of US sales
  • JNJ: at least 56 percent of US sales
  • PFE: at least 26 percent of US sales
  • MRK: at least 25 percent of US sales
  • LLY: at least 22 percent of US sales
  • TKPYY: at least 21 percent of US sales
  • AZN: at least 6 percent of US sales

 

Exhibit 1 does not establish whether all or just part of the product supply chain resides on the island, nor does it establish whether parallel manufacturing facilities for these products exist off the island

Manufacturers will commonly locate key steps in the manufacturing process in at least two geographically separate locations, and US and non-US supply chains often are partly segregated, both to provide demand volume for separate locations and to serve as a barrier to reimportation. We searched EMA approvals for drugs that we know are manufactured (at least in part) in Puerto Rico, to determine whether non-Puerto Rico sources for these products are likely to be available. For each manufacturing site listed in EMA documents, we cross-referenced FDA facilities registrations to determine which facilities (and within facilities which types of activities) are FDA licensed. Results are provided in Exhibit 2

 

In response to damage BAX’s Puerto Rico facilities sustained during Hurricane Maria, FDA recently worked with BAX to temporarily allow the importation of sterile infusion bags from sites in Australia and Ireland. Both sites had FDA licenses in place before the hurricanes, and we believe these licenses facilitated their role in temporarily supplying the US

ABBV

ABBV’s Humira has four sources of active pharmaceutical ingredient; Barceloneta, Puerto Rico has been the main source of US Humira, after taking over from the ABBV plant in Worcester, MA. When manufacturing was shifted from MA to PR the company stated that the MA facility would serve as an alternative source of active ingredient for the US. Lonza Biologics facilities in Spain and Singapore also are listed on the EMA approvals as sources for Humira active ingredient. All of these plants have current FDA licenses for analysis and manufacturing, leaving only the question of whether these facilities can, if necessary, ramp production quickly enough to fill in for Barceloneta. Humira throughput in the MA facility is likely to have been limited as this facility shifted to support other products; and, throughput in the Lonza facilities is likely to have been limited by the introduction of adalimumab biosimilars in Europe. ABBV’s EMA documents for Humira show two non-Puerto Rico based manufacturers with authority to batch release, one of which (Ludwigshafen, Germany) is FDA licensed

AMGN

AMGN has two FDA-licensed non-Puerto Rico sources of active pharmaceutical ingredient, and one FDA-licensed non-Puerto Rico source of packaging, for each of Enbrel, Neulasta, and Xgeva. We did not identify non-Puerto Rico sources of active pharmaceutical ingredient for either Repatha or Aranesp, nor did we identify a non-Puerto Rico source of packaging for Aranesp

BMY

Opdivo has three FDA-licensed, non-Puerto Rico sources of active pharmaceutical ingredient, and one FDA-licensed, non-Puerto Rico source of packaging. Opdivo has two FDA-licensed, non-Puerto Rico sources of active pharmaceutical ingredient, and one FDA-licensed, non-Puerto Rico source of packaging. Nulojix has one non-Puerto Rico source of active pharmaceutical ingredient, and one non-Puerto Rico source of packaging, both of which are FDA licensed. We were unable to find any FDA-licensed sources of active pharmaceutical ingredient for Eliquis other than the company’s facility in Humacao, Puerto Rico; however, the brand does have two non-Puerto Rico sources of packaging that are FDA-licensed

JNJ

We identified two FDA-licensed non-Puerto Rico sources of active pharmaceutical ingredient, and one FDA-licensed non-Puerto Rico source of packaging for Remicade. We could not identify any FDA-licensed sources of active pharmaceutical ingredient for Xarelto, Prezista, Invokana or Invega/Sustenna other than the company’s facility in Gurabo, Puerto Rico. We were also unable to find any FDA-licensed non-Puerto Rico source of packaging for Xarelto. We did find two FDA-licensed non-Puerto Rico sources of packaging for Prezista, and one each for Invokana and Invega/Sustenna

LLY

We found two FDA-licensed non-Puerto Rico sources of active pharmaceutical ingredient for Humalog, and two FDA-licensed non-Puerto Rico sources of packaging. For Basaglar, we found one each of FDA-licensed non-Puerto Rico facilities for active pharmaceutical ingredient and packaging. Puerto Rico is identified as a product source for Strattera in its FDA approval letter; however the specific location is not identified, and we were unable to identify any manufacturing locations from Strattera’s EMA documents

MRK

Puerto Rico is identified as a product source in Januvia’s approval documents; however, trade reports suggest manufacturing may have been moved off of the island as of 2016. MRK has two FDA licensed, non-Puerto Rico facilities listed for Januvia in the product’s EMA approvals; both are licensed for manufacturing, and one is also licensed for packing

Puerto Rico (Arecibo) is identified as a source for Zetia in a trade publication (see endnote 31); we were unable to identify any manufacturing locations from Zetia’s EMA approvals

PFE

We were unable to identify any non-Puerto Rico sites of active pharmaceutical ingredient manufacture for Lyrica, Eliquis (see BMY), or Xeljanz; however all three brands have either one (Lyrica, Xeljanz) or two (Eliquis) FDA-licensed, non-Puerto Rico sources of packaging

Viagra was and may still be made in Barceloneta, Puerto Rico; however indications are that Viagra manufacturing would be moved off of the island in 2017

Takeda

We located one each of FDA-licensed non-Puerto Rico facilities for active pharmaceutical ingredient and packaging for Entyvio

 

 

  1. “Reliance on Puerto Rico Manufacturing, by Major Pharmaceutical Firm,” October 11, 2017, SSR Health, LLC
  2. https://www.accessdata.fda.gov/scripts/cder/drls/default.cfm
  3. European Medicines Agency

 

©2017, SSR, LLC, 225 High Ridge Rd, 2nd Floor, Stamford, CT 06905. All rights reserved. The information contained in this report has been obtained from sources believed to be reliable, and its accuracy and completeness is not guaranteed. No representation or warranty, express or implied, is made as to the fairness, accuracy, completeness or correctness of the information and opinions contained herein. The views and other information provided are subject to change without notice. This report is issued without regard to the specific investment objectives, financial situation or particular needs of any specific recipient and is not construed as a solicitation or an offer to buy or sell any securities or related financial instruments. Past performance is not necessarily a guide to future results. In the past 12 months, through a wholly-owned subsidiary SSR Health LLC has provided paid advisory services to Pfizer Inc (PFE), Gilead Sciences (GILD), Bristol-Myers Squibb (BMY) and Sanofi (SNY) on both securities-related and non-securities-related topics. One or more of SSR Health’s analysts owns long positions in the following stocks: AAAP, AERI, AGEN, ALKS, ANAB, ARRY, BMY, DOVA, ESALY, GILD, GWPH, INCY, INVVY, IONS, KMPH, LJPC, NSTG, PFSCF, PTLA, RARE, RHHBY, RIGL, THERF, TSRO, VRTX

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