Sterling Pharmaceutical Services LLC

Verrica's Ycanth has been approved by the FDA, becoming the first treatment for molluscum, an under-diagnosed skin condition that strikes roughly 6 million in the U.S. each year. After two rejections from the FDA—both related to manufacturing—Verrica Pharmaceuticals has scored approval for Ycanth (cantharidin/VP-102), which becomes the first therapeutic sanctioned in the United States for molluscum, a viral skin infection. On Monday, after the Friday thumbs up from the FDA, Verrica said it was entering a non-binding term sheet for up to $125 million in debt financing to support the launch, which will come in late September. When Verrica closes the loan deal, which it expects to do by the end of this week, the company will borrow $50 million immediately, it said. That, in addition to the $60 million in cash and equivalents it had on hand at the end of the first quarter, extends the company’s runway to the first quarter of 2025, Verrica said. Hours after Monday’s revelation of the loan, Verrica’s shares had dipped by 30% from close on Friday. This is the first approval for the 10-year-old company which is based in West Chester, Pa. and specializes in dermatology therapeutics for skin diseases. The company also is investigating cantharidin as a treatment for genital warts and common warts. Molluscum is an under-diagnosed contagious condition that strikes roughly 6 million annually in the U.S., most of them children. The approval of the topical treatment covers those ages 2 and older. Molluscum is spread by skin-to-skin contact or by contact with objects that can carry the virus such as toys, towels or other wet surfaces. It causes raised lesions that can produce inflammation, itching and bacterial infection. The lesions can last for years and sometimes produce permanent scarring. The company estimates that only 15% of molluscum cases are diagnosed but CEO Ted White said in a conference call on Monday that he expects more diagnoses now that a treatment has been endorsed. The company projects the market to be 1 million patients per year. “Right now, we’re staffed to capture about 85% of the market,” Joe Bonaccorso, the company’s chief commercial officer, said on the call. The company has yet to arrive at a price for Ycanth. That should come sometime next month, added CFO Terry Kohler. The approval was based on two phase 3 trials, which enrolled 518 patients and showed that VP-102 produced 50% clearance of lesions versus 15% for those on a placebo treatment. Results remained consistent when comparing age groups and location of lesions. The approval was a long time coming after Verrica was hit with complete response letters (CRLs) in September 2021 and May 2022. In between the two rejections, Verrica’s contract manufacturer Sterling Pharmaceuticals Services was placed on official action indicated (OAI) status, which is the most serious category of violation. After the second CRL, Verrica said that—in addition to working with Sterling to remedy the problems—that it was also engaging another CMO to supply the drug.

SAN FRANCISCO, June 6, 2023 /PRNewswire/ -- The global active pharmaceutical ingredients and high potency API industry size stood at USD 233.31 billion in 2021 and is poised to observe a CAGR of 6% from 2022 to 2030, according to the "Active Pharmaceutical Ingredients and High Potency API Industry Data Book, 2023 – 2030," published by Grand View Research. Demand for the medicine that produces the intended therapeutic effects has witnessed an upward trajectory among pharmaceutical drug companies. The notable penetration of oncology drugs and precision medicine will favor the growth of API and HPAPI technologies. API has become a lucrative option for venture capitalists, investors, pharma majors and other stakeholders. Of late, innovative APIs have garnered traction in the wake of bullish regulation on R&D activities and novel drug development. Besides, the adoption of a sedentary lifestyle and soaring cancer cases have propelled the development of API. The global API market size was valued at USD 209.71 billion in 2021 and will exhibit a 5.9% CAGR between 2022 and 2030. Robust projection is partly due to R&D efforts to produce generic APIs. Moreover, personalized medicine has gained an uptick from the surging demand for targeted therapies, a trend likely to foster industry growth. CMOs and CDMOs have furthered their focus on HPAPI manufacturing and development to keep up with the drug demand for antibody drug conjugates and oncology. To illustrate, in March 2022, Lonza announced laboratory expansion at its API manufacturing site in China. It will underpin the early-phase highly-potent API manufacturing capabilities and help the company boost clinical trials in oncology. The global high potency API market size stood at USD 23.60 billion in 2021 and is slated to depict a CAGR of 6.2% through 2030. Order your copy of the Free Sample of " Active Pharmaceutical Ingredients and High Potency API Industry Data Book - Active Pharmaceutical Ingredients and High Potency Active Pharmaceutical Ingredients Market Size, Share, Trends Analysis, And Segment Forecasts, 2023 - 2030" Data Book, published by Grand View Research Industry leaders are counting on the high efficiency of HPAPI molecules to solidify their position in the global landscape. In March 2022, Novasep announced an infusion of €5.1 million (approximately USD 5.5 million) to bolster the production capacity for HPAPIs in France. The company expects it to propel its position in manufacturing innovative and targeted molecules for cancer treatment and undergird its footprint in the antibody drug conjugates space. Incumbents across North America, Europe, Asia Pacific, Latin America and Middle East & Africa will potentially bolster their API and HPAPI portfolios. In doing so, the following dynamics are expected to hold prominence: Synthetic APIs and HPAPIs will hold prominence in the wake of increased raw material availability and higher effectiveness in treatment. Laboratories expansion will redefine the global landscape. Polpharma is anticipating opening a new R&D & Production facility in the first quarter of 2024, which will include analytical laboratories (ADL) for Quality Control analyses and separate process laboratories (PDL), among others. The North America market will witness bullish investments on the back of growing cancer-related morbidity, mortality and cases. A study published in the American Cancer Society journal noted that 1,958,310 new cancer cases and 609,820 cancer deaths would be witnessed in the U.S. in 2023. Go through the table of content of Active Pharmaceutical Ingredients and High Potency API Industry Data Book to get a better understanding of the Coverage & Scope of the study Forward-looking companies envisage Asia Pacific to provide compelling growth opportunities, relying on the advanced chemical sector, rigorous manufacturing and quality standards, skilled manpower and reduced costs. Furthermore, governments have ramped up initiatives and schemes to provide a favorable platform for stakeholders. For instance, in March 2022, India started local manufacturing of 35 APIs under the Production Linked Incentive (PLI) Scheme. Key players have propelled their API portfolio to tap into the global market. In June 2022, WuXi announced the opening of an HPAPI production facility in China with milling technology and flow chemistry. With the pharmaceutical industry brimming with growth and innovations, Asia Pacific is touted to witness investment abound. In April 2023, the U.S. FDA gave the nod to Ajinomoto Bio-Pharma Services' HPAPI fill line to manufacture a commercial product. The competitive scenario indicates that well-established players and startups could inject funds into product offerings, technological advancements, innovations, geographical expansion, partnerships and mergers & acquisitions. To illustrate, in January 2023, Sterling Pharma announced the completion of the acquisition of Novartis' API manufacturing facility in Ireland, a significant step to bolster its position in the Europe market. Check out more Industry Data Books, published by Grand View Research About Grand View Research Grand View Research, U.S.-based market research and consulting company, provides syndicated as well as customized research reports and consulting services. Registered in California and headquartered in San Francisco, the company comprises over 425 analysts and consultants, adding more than 1200 market research reports to its vast database each year. These reports offer in-depth analysis on 46 industries across 25 major countries worldwide. With the help of an interactive market intelligence platform, Grand View Research Helps Fortune 500 companies and renowned academic institutes understand the global and regional business environment and gauge the opportunities that lie ahead. Contact: Sherry James Corporate Sales Specialist, USA Grand View Research, Inc. Phone: 1-415-349-0058 Toll Free: 1-888-202-9519 Email: [email protected] Web: Follow Us: LinkedIn | Twitter Logo - SOURCE Grand View Research, Inc.

Since it first formed a partnership with GHO in 2019, Sterling has grown rapidly tripling its revenues and quadrupling earnings, the companies say. GHO is a European specialist investor in healthcare worldwide while Partners Group is a private markets firm and Sterling, a contract development and manufacturing organization (CDMO). Sterling provides a full range of CDMO services 'across the lifecycle of new, high-value active pharmaceutical ingredients (APIs)' and quotes itself as an industry leader in the early-stage development of antibody drug conjugates (ADCs), a fast-growing class of cancer treatments. Kevin Cook, CEO at Sterling said: “We have achieved remarkable growth over the last four years becoming a trusted partner to the pharmaceutical and biotechnology industries. We are proud of our success in meeting the often complex and demanding manufacturing needs of our customers on an international scale.” Cook said continued sustainable growth has been underpinned by its partnership with GHO Capital, which has been instrumental in their success to date. He added: “We are delighted to welcome Partners Group, which, alongside GHO, will support our ambitious global growth trajectory. We look forward to continuing to provide industry leading service throughout the entire product lifecycle, to an ever-expanding international customer base.” Sterling says it focuses on handling the development of complex APIs and subsequent scaling up of manufacturing from pre-clinical to commercial scale. The company has five state-of-the-art manufacturing facilities in the US, UK, and Ireland. It also says it benefits from a ‘diversified blue-chip customer base’ and is a ‘supply chain partner for the majority of the largest pharmaceutical companies. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Since partnering with GHO in 2019, Sterling says it has grown rapidly and has transformed from a single-site UK CDMO to a global full-service complex small molecule API platform with differentiated chemistry capabilities. Sterling’s acquisition of Novartis’ Ringaskiddy site saw the company significantly increase its capacity, which included a long-term supply agreement with Novartis – which the company says reinforced Sterling’s outstanding reputation within the pharmaceutical industry. Partners Group has acquired a significant minority stake, bringing its knowledge of international healthcare, helping drive ‘future value creation’. GHO will remain Sterling’s majority shareholder and the current management team will continue to lead the company. This new investment from GHO is supported by a consortium of investors, led by funds managed by AlpInvest Partners, a subsidiary of global investment firm Carlyle and Pantheon. The partners at GHO Capital said: “We partner with management teams to deliver the healthcare of the future. Sterling is a leading example of how our deep industry expertise, combined with the GHO growth playbook, can generate long-term, sustainable value. We are immensely proud of the business that Sterling has become.”