Sol-Gel Technologies Announces Seventh Agreement for Generic Product Candidates with Perrigo

NESS ZIONA, Israel, May 28, 2019 (GLOBE NEWSWIRE) — Sol–Gel Technologies, Ltd. (NASDAQ: SLGL) ("Sol–Gel" or the "Company"), a clinical–stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced that it has entered into a seventh collaborative agreement with Perrigo Israel, an affiliate of Perrigo Company plc ("Perrigo") (NYSE; TASE: PRGO), for the development, manufacturing and commercialization of two new generic formulations of antibiotic foams.

Consistent with Sol–Gel's prior agreements with Perrigo, Perrigo will seek regulatory approval with the U.S. Food and Drug Administration ("FDA") for these generic product candidates. If approved by the FDA, Perrigo has agreed to commercialize the generic product candidates in the United States. Sol–Gel and Perrigo will share the development costs and the gross profits generated from sales of the generic product candidates, if approved.

"Sol–Gel is pleased at the opportunity to continue to build its successful, revenue–generating portfolio of complex generics with first to file potential with its partner, Perrigo, as well as help further their vision of affordable prescription generics," stated Dr. Alon Seri–Levy, Chief Executive Officer of Sol–Gel. "With top–line revenue being generated from our generics portfolio, we look forward to continuing the development of our innovative, branded products which are currently in Phase 3 pivotal trials with top–line data expected in mid–2019 for Epsolay and TWIN in the fourth quarter of this year."

About Sol–Gel Technologies

Sol–Gel is a clinical–stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases. Sol–Gel's current product candidate pipeline consists of late–stage branded product candidates that leverage our proprietary, silica–based microencapsulation technology platform, and several generic product candidates across multiple indications. For additional information, please visit www.sol–gel.com.

Forward–Looking Statements

This press release contains "forward–looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward–looking statements, including, but not limited to, the clinical progress of our product candidates, plans and timing for the release of clinical data and our expectations surrounding the progress of our generic product portfolio . These forward–looking statements include information about possible or assumed future results of our business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward–looking statements by terminology such as "believe," "may," "estimate," "continue," "anticipate," "intend," "should," "plan," "expect," "predict," "potential," or the negative of these terms or other similar expressions. Forward–looking statements are based on information we have when those statements are made or our management's current expectation, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward–looking statements. Important factors that could cause such differences include, but are not limited to: (i) the adequacy of our financial and other resources, particularly in light of our history of recurring losses and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; (ii) our ability to complete the development of our product candidates; (iii) our ability to find suitable co–development partners; (iv) our ability to obtain and maintain regulatory approvals for our product candidates in our target markets and the possibility of adverse regulatory or legal actions relating to our product candidates even if regulatory approval is obtained; (v) our ability to commercialize our pharmaceutical product candidates; (vi) our ability to obtain and maintain adequate protection of our intellectual property; (vii) our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; (viii) our ability to establish adequate sales, marketing and distribution channels; (ix) acceptance of our product candidates by healthcare professionals and patients; (x) the possibility that we may face third–party claims of intellectual property infringement; (xi) the timing and results of clinical trials that we may conduct or that our competitors and others may conduct relating to our or their products; (xii) intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; (xiii) potential product liability claims; (xiv) potential adverse federal, state and local government regulation in the United States, Europe or Israel; and (xv) loss or retirement of key executives and research scientists. These and other important factors discussed in the Company's Annual Report on Form 20–F filed with the Securities and Exchange Commission ("SEC") on March 21, 2019 and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward–looking statements made in this press release. Any such forward–looking statements represent management's estimates as of the date of this press release. Except as required by law, we undertake no obligation to update publicly any forward–looking statements after the date of this press release to conform these statements to changes in our expectations.

For further information, please contact:
Sol–Gel Contact:
Gilad Mamlok
Chief Financial Officer
+972–8–9313433

Investor Contact:
Chiara Russo
Solebury Trout
+1–617–221–9197
crusso@soleburytrout.com

Source: Sol–Gel Technologies Ltd.

Finance’s New Avatar

By Jomo Kwame Sundaram and Michael Lim Mah Hui
KUALA LUMPUR and PENANG, May 28 2019 – Over recent decades, the scope, size, concentration, power and even the purpose and role of finance have changed so significantly that a new term, financialization, was coined to name this phenomenon.

Financialization refers to a process that has not only transformed finance itself, but also, the real economy and society. The transformation goes beyond the quantitative to involve qualitative change as finance becomes dominant, instead of serving the needs of the real economy.

Jomo Kwame Sundaram

Financialization involves the growth and transformation of finance such that with its hugely expanded size, scope and concentration, finance now overshadows, dominates and destabilizes the productive economy.

The role and purpose of finance has been qualitatively transformed. Finance used to profit from serving production and trade. Traditionally, financing production involved providing funds for manufacturers to finance production, and for traders to buy and sell.

Financialization, on the other hand, turns every imaginable product or service into financial commodities or services to be traded, often for speculation. Instead of seeking profits by financing the productive economy and trade, finance is now more focused on extracting rents from the economy.

Finance is hegemonic, dominating all of society without appearing to do so, transforming more and more things into financial products and services to be traded and sold. But financialization could not have happened on its own.

Its nature and pace have been enabled and shaped by ideological, legal, institutional and deliberate policy and regulatory changes. Regulatory authorities, both national and international, can barely keep up with its transformative consequences.

Size matters
One aspect of financialization refers to the size of finance relative to the whole economy, with the financial sector growing faster and securing more profit than other sectors. The simplest and most popular measure of finance uses national income accounts for ‘finance, insurance and real estate’ (FIRE).

Michael Lim Mah Hui

In the US, finance’s share of GDP grew from 14% to 21% between 1960 and 2017, while manufacturing’s fell from 27% to 11%, and trade’s declined from 17% to 12%. The financial sector is almost twice as large as both trade and manufacturing sectors.

The growth of shadow banking, referring to activities similar to traditional banking undertaken by non-bank financial institutions that are not regulated as banks, is a growing and significant source of credit and accounts for much of the growth of finance.

Such institutions include hedge funds, private equity funds, mortgage lenders, money market funds and insurance companies. These financial institutions, including traditional banks, have used securitization, ‘off-balance sheet’ derivative positions and leverage to create, manage and trade securities and derivatives, ballooning its business volume.

With heightened concerns about growing financial fragility, more sophisticated measures have been introduced to estimate ‘shadow banking’. Most country-level measures show shadow banking increasing rapidly before, and more worryingly, after the 2008-2009 global financial crisis!

At the same time, finance has also secured the most gains in the US, taking advantage of the sector’s ability to leverage more than non-financial corporations, engaging in financial innovations and trading complex and opaque products netting super profits.

During 1960-2017, finance almost doubled its profits, from 17% to 30% of total domestic corporate profits, while manufacturing’s share shrank by almost two thirds from 49% to 17%.

Jim Reid of Deutsche Bank estimated that that the US financial sector made around US$1.2 trillion (US$1,200 billion) in ‘excess profits’, relative to the previous mean, in the decade before the 2008 global financial crisis.

Greater concentration
There are contrasting views of whether bank concentration leads to greater or less financial stability. But size certainly does not guarantee either good banking practices or financial stability.

In fact, the global financial crisis suggests that the “too big to fail” syndrome encouraged moral hazard. Big banks take on excessive risk as they believe they have a safety net — governments will bail them out to prevent a financial system collapse.

Over the years, US banking has become more concentrated. This accelerated with the abolition of the Glass-Steagall Act and its replacement with the Graham-Leah-Bliley Act in 1999 which saw the creation of universal bank behemoths combining commercial and investment banking activities.

The top five banks in 1990 held less than 10% of total bank assets; by 2007, they had 44%. Seven years after the 2008-2009 Global Financial Crisis, the US banking industry is just as concentrated, with the top five banks – JP Morgan Chase, Bank of America, Wells Fargo, Citibank and US Bancorp – holding US$7 trillion, or 44% of total bank assets.

Meanwhile, asset management is even more concentrated than banking. Together, the ‘Big Three’ – Blackrock, Vanguard and State Street – are the largest shareholders in four-fifths of listed US corporations, managing nearly US$11 trillion, thrice the worth of global hedge funds. Such asset management relies on banks for leveraged access to financial markets.

Undoubtedly, many regulators have replaced previously weak regulation, which failed to check spreading systemic risk before the 2008-2009 global financial crisis, with new rules. But these do not seem to have effectively checked more recent abusive practices.

Recent technological, ideological, institutional and political changes have drastically transformed finance, enabling it to penetrate and dominate all spheres of life such that financialization is the new avatar.

Jomo Kwame Sundaram, a former economics professor, was United Nations Assistant Secretary-General for Economic Development, and received the Wassily Leontief Prize for Advancing the Frontiers of Economic Thought.

Dr Michael LIM Mah Hui has been a university professor and banker, in the private sector and with the Asian Development Bank.