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| Retrophin, Inc. | |
|---|---|
| Name | Retrophin, Inc. |
| Type | Public |
| Industry | Biotechnology |
| Founded | 2011 |
| Founder | Martin Shkreli |
| Headquarters | San Diego, California, United States |
| Key people | Joseph Perlman; Martin Shkreli (founder) |
| Products | Chenodal; Chenodeoxycholic acid formulations; Firdapse; Amifampridine; Thiola; Tiopronin |
Retrophin, Inc. is an American biotechnology and specialty pharmaceutical company focused on rare and orphan diseases, headquartered in San Diego, California. The company was founded in 2011 and developed therapies including therapies derived from chenodeoxycholic acid and amifampridine. Retrophin has been involved in high-profile legal and regulatory matters related to executive conduct, intellectual property, and pharmaceutical pricing, intersecting with institutions such as the Securities and Exchange Commission, United States Department of Justice, and various district courts.
Retrophin was founded in 2011 by Martin Shkreli with early financing and board involvement that connected to investors associated with Kissinger Associates, QVT Financial, and other private equity firms. The company's initial strategy emphasized acquiring approved therapies for rare disorders and pursuing regulatory pathways through the Food and Drug Administration and European Medicines Agency to expand indications. In 2014–2015 Retrophin's growth and pricing strategies drew scrutiny from health policy observers in the wake of controversies that involved lawmakers from the United States Congress and hearings influenced by advocacy groups similar to Patients for Affordable Drugs Now and organizations aligned with PhRMA. Following legal actions against its founder, leadership change initiatives paralleled corporate governance reforms recommended by proxy advisory firms like ISS and Glass Lewis. Over subsequent years the company refocused through mergers, acquisitions, and divestitures while engaging with market actors including Catalyst Pharmaceuticals, Pfizer, and specialty distributors active in the orphan drug sector.
Retrophin is organized as a publicly traded company with a board of directors and executive officers overseeing operations from its headquarters in San Diego and corporate offices in hubs such as New York City and San Francisco. Its governance has been shaped by interactions with regulatory agencies including the Securities and Exchange Commission and adjudications in federal venues such as the United States District Court for the Southern District of New York. Leadership transitions included interim and permanent CEOs, finance chiefs, and general counsels who navigated relationships with institutional investors like BlackRock, Vanguard, and hedge funds linked to prior management controversies. The board has engaged outside advisers, law firms with litigation practices before the United States Court of Appeals for the Second Circuit, and accounting firms active with Public Company Accounting Oversight Board oversight.
Retrophin's marketed products have included formulations of chenodeoxycholic acid marketed under trade names such as Chenodal for rare bile acid disorders, and amifampridine marketed as Firdapse for Lambert–Eaton myasthenic syndrome. The company has also maintained programs for thiol-based therapies such as tiopronin (marketed as Thiola) for cystinuria and pursued orphan drug designations through the Food and Drug Administration's Office of Orphan Products Development and regulatory pathways associated with European Medicines Agency orphan frameworks. Research collaborations involved preclinical and clinical studies conducted at academic centers including Johns Hopkins University, Mayo Clinic, Cleveland Clinic, and international trial sites coordinated with contract research organizations and institutional review boards like those at Stanford University and Harvard Medical School.
As a publicly traded specialty biopharma, Retrophin's financial results reflected revenues from orphan product sales, royalty arrangements, and corporate transactions. Financial reporting submitted to the Securities and Exchange Commission detailed revenue recognition for products distributed through specialty pharmacies and third-party payers including government programs like Medicare and private insurers influenced by pharmacy benefit managers such as Express Scripts. Market reactions to litigation and leadership changes were reflected in trading on exchanges influenced by analysts at firms comparable to Goldman Sachs, Morgan Stanley, and boutique healthcare-focused funds. Capital transactions included public offerings, private placements, and licensing deals comparable to arrangements seen with companies like Catalent and Mallinckrodt in the orphan drug market.
Retrophin's public profile has been shaped by legal controversies, most notably criminal and civil matters involving its founder that engaged the United States Department of Justice, the Securities and Exchange Commission, and federal prosecutors in New York. Litigation encompassed allegations of securities fraud prosecuted in the United States District Court for the Southern District of New York and subsequent civil claims for alleged breaches of fiduciary duty and improper contract practices. The company faced intellectual property disputes and pricing controversies that drew commentary from policy bodies such as the U.S. Senate and state attorneys general. Settlements, injunctions, and appellate decisions in courts including the United States Court of Appeals for the Second Circuit shaped corporate remedies and compliance programs.
Retrophin engaged in strategic collaborations with academic institutions, biotechnology firms, and specialty distributors to develop and commercialize orphan therapies. Partnerships included licensing negotiations and supply agreements with pharmaceutical companies and contract manufacturing organizations resembling partnerships seen in the biotech sector with Catalyst Pharmaceuticals, Mallinckrodt Pharmaceuticals, Teva Pharmaceutical Industries, and manufacturing collaborators aligned with Thermo Fisher Scientific and Lonza. Clinical research partnerships involved universities such as University of California, San Diego, Columbia University, and international research centers coordinated through global trial sponsors and regulatory consultants experienced with International Council for Harmonisation standards.
Retrophin maintained engagement with patient advocacy groups representing rare disease communities, supporting disease registries, educational initiatives, and collaborations with organizations similar to NORD (National Organization for Rare Disorders), Global Genes, and patient foundations affiliated with academic centers like Boston Children's Hospital. Philanthropic activities included support for caregiver resources, research grants at institutions such as Yale School of Medicine and partnerships with advocacy coalitions that interface with policymakers in Washington, D.C. and state capitals to advance rare disease awareness and orphan drug policy reform.
Category:Biotechnology companies of the United States Category:Pharmaceutical companies established in 2011