Meditrina

In June 2020, Meditrina, Inc. announced a $20 million tranched Series C financing round. The Company is commercializing innovative medical devices for minimally invasive gynecologic procedures, offering patients and physicians more advanced, convenient, and cost-effective options.

Frequency Therapeutics, Inc.

In July 2019, Frequency Therapeutics, Inc. announced the closing of a $62 million Series C round financing. The Company is focused on developing small molecules to activate progenitor cells in the body to restore healthy tissues.

Proceeds will be used to further support the Company’s Progenitor Cell Activation (PCA) technology. Frequency’s lead compound, FX-322, activates the regrowth of sensory cells in the inner ear to treat chronic noise induced hearing loss.

Shine and Deerfield Close $150 Million Financing Commitment to Support Diagnostic and Therapeutic Medical Isotope Manufacturing

New York, NY and Janesville, WI – SHINE Medical Technologies Inc. (SHINE), a Wisconsin-based company dedicated to being the world leader in the safe, clean, affordable production of medical isotopes, and Deerfield Management Company, a healthcare investment firm, announced today the closing of a definitive agreement providing a $150 million financing commitment to support diagnostic and therapeutic medical isotope manufacturing. The Company’s first product, molybdenum-99 (Mo-99), will address current chronic shortages of the isotope, which is currently relied on for 80% of all nuclear medicine procedures.

“We are enthusiastic about partnering with SHINE to help create a permanent and dependable solution to the industry’s Mo-99 shortage and to work on developing other medical isotopes for therapeutic use,” said Steve Hochberg, Partner at Deerfield. “We look forward to continuing to work with the talented SHINE team and supporting them as the company scales and executes to address this important need.”

Deerfield’s investment will be used for the construction of SHINE’s main production facility, which will start in the spring of 2019. The investment is tranched, based on SHINE achieving milestones. At full capacity, the SHINE facility will be able to supply over one third of global demand for Mo-99. The investment will also provide capital to ramp up operations prior to commencing commercial production of Mo-99, expected to begin in 2021.

“We are excited to sign this deal as we begin construction of our Janesville production facility,” said Greg Piefer, SHINE founder and CEO. “Deerfield is a world-leading healthcare investment firm and is a strong partner that provides important institutional validation of our business.”

Prior to signing the Deerfield agreement, SHINE also closed its Series B funding round, bringing in over $30M of investment through private investors. “The Series B round was largely driven by the support of in-state investors and strategic partners. We are extremely grateful to know that the State of Wisconsin and our industry partners believe in the SHINE vision and opportunity,” said Todd Asmuth, President and CFO of SHINE.

About Medical Isotopes

Medical isotopes are radioisotopes that are used in the diagnosis and treatment of disease. Molybdenum-99 (Mo-99) is a radioisotope that decays into the diagnostic imaging agent technetium-99m (Tc-99m). The workhorse of nuclear medicine, Tc-99m is used in more than 40 million medical imaging procedures each year, primarily in stress tests to diagnose heart disease and bone scans to stage cancer. SHINE was founded to deploy a safe, cost-effective and environmentally friendly technology to produce a variety of medical isotopes, including Mo‑99. Roughly 1% of all Mo-99 in the world decays every hour, meaning it must be continuously produced. Current production is limited to only a handful of government-owned nuclear research reactors, the majority of which are overseas.

About Deerfield Management Company

Deerfield is an investment management firm committed to advancing healthcare through investment, information and philanthropy. For more information about Deerfield, please visit www.deerfield.com.

About SHINE Medical Technologies, Inc.

Founded in 2010, SHINE is a development-stage company working toward becoming a manufacturer of radioisotopes for nuclear medicine. The SHINE system uses a patented, proprietary manufacturing process that offers major advantages over existing and proposed production technologies, as it does not require a nuclear reactor, uses less electricity, generates less waste and is compatible with the nation’s existing supply chain for molybdenum-99. In 2014, SHINE announced the execution of molybdenum-99 supply agreements with GE Healthcare and Lantheus Medical Imaging. In 2015, with the help of Argonne National Laboratory, GE Healthcare demonstrated SHINE molybdenum-99 can act as a drop-in replacement for reactor-based moly-99. In 2016, SHINE received regulatory approval to construct its facility from the Nuclear Regulatory Commission and signed a moly-99 supply agreement with HTA Co., Ltd., the largest Chinese distributor of radiopharmaceuticals. In 2017, SHINE built the first building on its Janesville campus: SHINE Building One. Learn more at http://shinemed.com.

Contact

Karen Heidelberger 
Chief Partnership and Communications Officer
Deerfield Management Company
212-551-1600
[email protected]

Katrina Pitas
VP of Business Development
SHINE Medical Technologies
(608) 210-1060
[email protected]

SHINE Medical Technologies

In November 2018, Deerfield closed a $150 million financing commitment to SHINE Medical Technologies, Inc. SHINE is a development-stage company working towards becoming a manufacturer of select radioisotopes for diagnostic and therapeutic applications. The SHINE system uses a patented proprietary manufacturing process that offers potential major advantages over existing and proposed production technologies as it does not require a nuclear reactor, uses less electricity, generates less waste and is compatible with the nation’s existing supply chain for molybdenum-99 (Mo-99).The company obtained its construction permit from the Nuclear Regulatory Commission in February 2016. Deerfield’s commitment will finance the construction of the plant. The first product is targeted to be Mo-99, which is used in medical imaging, but the company will manufacture additional isotopes over time.

Press releases

Deerfield Management Company Announces a $125 million Term Sheet with SHINE Medical Technologies, Inc.
October 2014

Shine and Deerfield Close $150 Million Financing Commitment to Support Diagnostic and Therapeutic Medical Isotope Manufacturing
November 2018

Proteon Therapeutics

In June 2017, Deerfield led funding for Proteon Therapeutics Inc. Proteon is developing first-in-class therapeutics to address the medical needs of patients with kidney and vascular diseases. Deerfield originally invested in Proteon in 2014 because of the substantial unmet medical need and confidence in the management team and technology.

Proteon Therapeutics

In May of 2014, Deerfield invested in Proteon Therapeutics, Inc. as part of $45 million Series D financing. Proteon is a development stage biopharmaceutical company developing novel, first-in-class pharmaceuticals to address the critical medical needs of patients with kidney and vascular diseases.

Phoenix Nuclear Labs, LLC

In April 2017, Deerfield provided the initial funding of a two tranched senior convertible debt with warrant instruments in Phoenix Nuclear Labs, LLC. Phoenix Nuclear Labs develops commercial neutron generators for use across a variety of applications within the healthcare, defense, and energy industries. The funding will be used to fund the production of new orders and operating costs.

Innovate, Regrow, Cure – The Politics Of Biomedical Innovation

When politics and science mix, we all hold our breath.

Several pieces of legislation have been floated in Congress over the past year with the shared objective of encouraging biomedical research and therapeutics.

These follow in the footsteps of other recent legislation designed to speed advances in medicine by modernizing regulatory processes. Even many skeptics of the Washington political process hail some of these efforts, such as Breakthrough Therapy Designation (BTD) and the Generating Antibiotics Incentives Now (GAIN) Act, both implemented in connection with 2012’s
Food and Drug Administration Safety and Innovation Act (FDASIA), as great successes. In 2015 alone, the FDA approved 45 new molecular entities, which included 10 with BTD  and 16 drugs with novel mechanisms of action. Almost half were drugs for rare diseases[1].

Critical to their success, these initiatives were designed through a collaborative process with buy-in from multiple stakeholders – including FDA, patient groups, and industry. 

More recently, H.R.6., known as the 21st Century Cures Act, was overwhelmingly passed by the House in July 2015. Its goal is “to accelerate the discovery, development and delivery of 21st century cures[2].” This legislation grew out of a bipartisan process, championed by Representatives Fred Upton (R, MI) and Diana DeGette (D, CO), that carefully constructed something about as close to a consensus as is possible in Washington today.  Patient groups, industry, academia, FDA, NIH and other stakeholders all had a voice in constructing a balanced package of reforms designed to enhance the medical innovation ecosystem.

Following in the footsteps of the House, Senate leaders from both parties are advancing the Senate’s so-called “innovation legislation,” a suite of bills that collectively are that Congressional body’s companion to the House’s 21st Century Cures. Those bills were discussed across three Senate Health Committee meetings in the first half of 2016, with a total of 19 bills approved by the committee as of April 2016[3].

Like FDASIA in 2012, these bills are the product of efforts to build consensus and alignment across stakeholders, including FDA, and they have the potential to further the advances that grew out of FDASIA. 

CDER New Molecular Entity (NME) and New Biologic License Application (BLA) Filings and Approvals
Source: FDA analysis[4]. Adapted from FDA.gov

At the same time, it is possible to push too far and too fast in trying to speed new therapies to market.  Earlier this year, legislation known as the Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW) Act was introduced into both houses of Congress. REGROW is a bill “to amend the Federal Food, Drug, and Cosmetic Act with respect to cellular therapies[5]” with the aim of supporting regenerative medicines. 

A major criticism of REGROW is that it would introduce significant changes that challenge the basic architecture of the new drug approval process. As one example, REGROW would allow for the sale of stem-cell therapies that have been shown to be safe but have not yet been proved effective. 

It is perhaps telling that multiple advocacy organizations in the field are opposed to REGROW – these include the Alliance for Regenerative Medicine (ARM), the International Society for Stem Cell Research[6], and most recently, a coalition of 10 patient advocacy groups that wrote a letter to Senator Mark Kirk (R, IL), the bill’s sponsor, expressing their shared concerns[7]

ARM noted “We continue to believe the proposal does not contain critical statutory protections for patients[8],” with the patient advocacy coalition similarly noting patient safety could be compromised with the conditional approval pathway stipulated by REGROW, and further, that it would be difficult for FDA to withdraw such products should it subsequently identify safety issues. 

The need for new drugs to demonstrate not only safety but also efficacy has been the cornerstone of FDA regulation since the 1962 Harris-Kefauver Amendments to the Federal Food, Drug, and Cosmetic Act, passed in response to the agency’s experience with thalidomide[9]. Critics, including FDA officials, have expressed concern that REGROW would upend over 50 years of standard practice at the agency. 

Most everyone agrees that there is room to continue to optimize the FDA approval process, and that regenerative medicine represents an area of enormous promise. Efforts to enhance FDA regulation, like the 21st Century Cures process, should be welcomed.  But any discussion of eliminating the requirement that new drugs be shown to be efficacious prior to FDA approval should be undertaken only with careful thought and buy-in from key stakeholders across the spectrum, including most importantly FDA itself.

Recent history has shown that Washington can act to advance biomedical innovation.  But efforts such as REGROW remind us of the dangers of mixing politics with science.

[1]http://cen.acs.org/articles/94/i5/Year-New-Drugs.html

[2]https://www.congress.gov/bill/114th-congress/house-bill/6?q=%7B%22search%22%3A%5B%2221st+century+cures%22%5D%7D&resultIndex=1

[3]http://www.alexander.senate.gov/public/index.cfm/pressreleases?ID=388C8CAC-698E-4CD0-A4C3-6929EFB9F0BD

[4]http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm474696.htm

[5]https://www.congress.gov/bill/114th-congress/house-bill/4762/text?q=%7B%22search%22%3A%5B%22REGROW%22%5D%7D&resultIndex=1

[6]http://www.politico.com/tipsheets/prescription-pulse/2016/05/new-legislation-on-stem-cells-raises-alarm-214069

[7]http://cdn.rarediseases.org/wordpresscontent/wp-content/uploads/2014/11/Letter_to_Senator_Kirk_REGROW_May_24.pdf

[8]http://alliancerm.org/page/government-relations-and-policy

[9]http://blogs.fda.gov/fdavoice/index.php/2012/02/50-years-after-thalidomide-why-regulation-matters/

Deerfield Leads Series 1-A financing for Hallux

New York, NY – December 16, 2015 – Deerfield leads a $7.1 million Series A investment in Hallux, Inc. to further the development of a novel dosage form and route of administration of leading antifungal terbinafine to treat distal subungual onychomycosis, a common infection of the nail plate. The studies are intended to establish tolerability, proof of concept and optimal dose.

“We are pleased to be able to work with Hallux to pursue improved cure rates for distal subungual onychomycosis, which is reported to affect as many as 35 million people in the United States. We believe the Hallux management team has identified and is developing a novel therapeutic delivery option that can result in meaningfully improved outcomes when treating this disease,” stated Peter Steelman, Partner at Deerfield Management.

“Deerfield has been a creative partner and supporter of innovation and we are pleased to have them on our team to help further develop our product and help guide our company to success,” stated Mark Taylor, CEO of Hallux.

About Hallux

Hallux, Inc. is a clinical-stage pharmaceutical company focused on the development of targeted subungual drugdelivery to treat onychomycosis. The Company’s lead product is designed to deliver high concentrations of terbinafine hydrochloride directly to the nail bed site of infection with negligible systemic exposure.

About Deerfield

Deerfield is an investment management firm committed to advancing healthcare through investment, information and philanthropy.

For more information, please visit www.deerfield.com.

Contacts

Deerfield Management Company
Karen Heidelberger, 212-692-7140
[email protected]

Hallux

Hallux, Inc. is a development stage pharmaceutical company based in Laguna Hills, CA. Deerfield led the $7.1 million Series A Preferred Equity to fund continued development of a novel pharmaceutical formulation of terbinafine to treat distal subungual onychomychosis, a common infection of the nail plate.